https://foiadocs.com/products/fda-510k-k162532-welldoc-bluestar-welldoc-bluestar-rx 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K162532, WellDoc BlueStar, WellDoc BlueStar Rx, by Welldoc, Inc. https://foiadocs.com/products/fda-510k-k162955-multi-modality-tumor-tracking-mmtt-application 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K162955, Multi-Modality Tumor Tracking (MMTT) application, by Philips Medical Systems Nederland B.V. https://foiadocs.com/products/fda-510k-k160811-crw-stereotactic-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160811, CRW STEREOTACTIC SYSTEM, by Integra LifeSciences Corporation https://foiadocs.com/products/fda-510k-k161682-ge-lunar-dxa-bone-densitometers-with-encore-version-17 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161682, GE Lunar DXA Bone Densitometers with enCORE version 17, by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC https://foiadocs.com/products/fda-510k-k162047-ligasure-impact-curved-large-jaw-open-sealer-divider-nano-coated 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K162047, LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated, by Covidien https://foiadocs.com/products/fda-510k-k161656-ambu-ascope-3-regular-5-0-2-2-ambu-ascope-3-slim-3-8-1-2-ambu-ascope-3-large-5-8-2-8-ambu-aview-monitor 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161656, Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor, by Ambu A/S https://foiadocs.com/products/fda-510k-k160147-ct-trueview 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160147, CT TrueView, by Philips Medical Systems Nederland B.V. https://foiadocs.com/products/fda-510k-k160629-inpen 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160629, InPen, by Companion Medical, Inc. https://foiadocs.com/products/fda-510k-k160364-versawrap-tendon-protector 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160364, VersaWrap Tendon Protector, by Alafair Biosciences, Inc. https://foiadocs.com/products/fda-510k-k160845-acquire-endoscopic-ultrasound-fine-needle-biopsy-fnb-device 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160845, Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device, by Boston Scientific Corporation https://foiadocs.com/products/fda-510k-k152111-symmetry-surgical-quad-lock-container-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152111, Symmetry Surgical Quad-Lock Container System, by Symmetry Surgical, Inc. https://foiadocs.com/products/fda-510k-k160434-clearpoint-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160434, ClearPoint System, by Mri Interventions, Inc. https://foiadocs.com/products/fda-510k-k151307-iconacytm-i-hip-tm 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151307, ICONACY(TM) I-Hip (TM), by Iconacy Orthopedic Implants, LLC https://foiadocs.com/products/fda-510k-k152082-vesocclude-polymer-ligating-clip 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152082, Vesocclude Polymer Ligating Clip, by Vesocclude Medical, LLC https://foiadocs.com/products/fda-510k-k153548-vs3-stereoscopic-high-definition-vision-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153548, VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM, by Visionsense, Ltd. https://foiadocs.com/products/fda-510k-k160068-filmarray-respiratory-panel-rp-for-use-with-filmarray-torch 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160068, FilmArray Respiratory Panel (RP) for use with FilmArray Torch, by Biofire Diagnostics, LLC https://foiadocs.com/products/fda-510k-k153203-navigation-instruments 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153203, Navigation Instruments, by Globus Medical, Inc. https://foiadocs.com/products/fda-510k-k160044-image1-spies-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160044, Image1 SPIES System, by Karl Storz Endoscopy America, Inc. https://foiadocs.com/products/fda-510k-k152311-pentacam-axl 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152311, Pentacam AXL, by Oculus Optikgerate GmbH https://foiadocs.com/products/fda-510k-k153618-capillus202 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153618, Capillus202, by Capillus, LLC https://foiadocs.com/products/fda-510k-k151662-irestore 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151662, iRestore, by Freedom Laser Therapy, Inc. https://foiadocs.com/products/fda-510k-k152491-mome-software-platform 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152491, MoMe Software Platform, by Infobionic, Inc. https://foiadocs.com/products/fda-510k-k152857-neomed-neoconnect-enteral-syringes-with-enfit-connector-and-compatible-neosecure-tip-caps 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152857, NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps, by Neomed, Inc. https://foiadocs.com/products/fda-510k-k151926-quickray-hd-intraoral-sensor 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151926, QuickRay HD Intraoral Sensor, by Denterprise International, Inc. https://foiadocs.com/products/fda-510k-k152060-3m-attest-rapid-readout-biological-indicator-1295 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152060, 3M Attest Rapid Readout Biological Indicator 1295, by 3M Company https://foiadocs.com/products/fda-510k-k150219-equashield-closed-system-drug-transfer-device-cstd 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150219, Equashield Closed System drug Transfer Device (CSTD), by Equashield Medical , Ltd. https://foiadocs.com/products/fda-510k-k150386-tyece-otc-tens-device 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150386, Tyece OTC TENS Device, by Tyece , Ltd. https://foiadocs.com/products/fda-510k-k151376-superdimension-navigation-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151376, superDimension Navigation System, by Covidien, LLC https://foiadocs.com/products/fda-510k-k142505-clearpoint-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142505, ClearPoint System, by Mri Interventions, Inc. https://foiadocs.com/products/fda-510k-k151988-visible-patient-suite 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151988, Visible Patient Suite, by Visible Patient, Sas https://foiadocs.com/products/fda-510k-k150222-x-guide-surgical-navigation-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150222, X-Guide Surgical Navigation System, by X-Nav Technologies, LLC https://foiadocs.com/products/fda-510k-k151777-intradermal-adapter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151777, Intradermal Adapter, by West Pharmaceutical Services, Inc. https://foiadocs.com/products/fda-510k-k152309-logiq-e9-logiq-e9-xdclear-2-0 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152309, LOGIQ E9, LOGIQ E9 XDClear 2.0, by GE Medical Systems Ultrasound and Primary Care Diagnostics https://foiadocs.com/products/fda-510k-k151324-straumann-variobase-for-cerec 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151324, Straumann Variobase for CEREC, by Straumann USA, LLC https://foiadocs.com/products/fda-510k-k150685-skynector-cpap-mask 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150685, Skynector CPAP Mask, by Sky Wise Medical Instrument (Shen Zhen) Co., Ltd. https://foiadocs.com/products/fda-510k-k151204-hemo-bandage 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151204, HEMO-Bandage, by Coreleader Biotech Co., Ltd. https://foiadocs.com/products/fda-510k-k151363-zephyr-vascular-compression-device 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151363, Zephyr Vascular Compression Device, by Advanced Vascular Dynamics https://foiadocs.com/products/fda-510k-k150906-ultrapro-advanced-macroporous-partically-absorbable-mesh 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150906, ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh, by Ehicon, Inc. https://foiadocs.com/products/fda-510k-k150850-refobacin-bone-cement-r 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150850, Refobacin Bone Cement R, by Biomet, Inc. https://foiadocs.com/products/fda-510k-k151340-harmonic-focus-long-shears-adaptive-tissue-technology 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151340, HARMONIC Focus Long Shears + Adaptive Tissue Technology, by Ethicon Endo-Surgery, LLC https://foiadocs.com/products/fda-510k-k151115-mr-core-software 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151115, MR Core Software, by Vital Images, Inc. https://foiadocs.com/products/fda-510k-k150042-pleuraflow-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150042, PleuraFlow System, by Clearflow, Inc. https://foiadocs.com/products/fda-510k-k143263-kangaroo-connect-enteral-feeding-pump-with-kangaroo-connect-feeding-sets 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143263, Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, by Covidien https://foiadocs.com/products/fda-510k-k143496-piccolo-composite-plate-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143496, Piccolo Composite Plate System, by CarboFix Orthopedics , Ltd. https://foiadocs.com/products/fda-510k-k150271-prime-adaptive-ultrasonic-scalpel-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150271, Prime Adaptive Ultrasonic Scalpel System, by Endoprime, Inc. https://foiadocs.com/products/fda-510k-k150151-smartgowntm-surgical-gown 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150151, SmartGownTM surgical gown, by Cardinal Health 200, Inc. https://foiadocs.com/products/fda-510k-k142319-scig60-infuser-infuset 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142319, SCIg60 Infuser, Infuset, by Emed Technologies Corporation https://foiadocs.com/products/fda-510k-k143714-powerheart-g5-aed 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143714, Powerheart G5 AED, by Cardiac Science Corporation https://foiadocs.com/products/fda-510k-k142282-hummingbirdtm-tympanostomy-tube-system-tts 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142282, HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS), by Preceptis Medical https://foiadocs.com/products/fda-510k-k150499-freestyle-deluxe-freestyle-solution-set-freestyle-basic-freestyle-motor-warranty 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150499, Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty, by Medela AG https://foiadocs.com/products/fda-510k-k143191-intellisense-drill 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143191, IntelliSense Drill, by Mcginley Innovations https://foiadocs.com/products/fda-510k-k143705-needlecam-hd-visualization-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143705, NeedleCam HD Visualization System, by Biovision Technologies, LLC https://foiadocs.com/products/fda-510k-k142881-dmrc-dual-cure-orthodontic-band-cement 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142881, DMRC Dual Cure Orthodontic Band Cement, by Danville Materials, LLC https://foiadocs.com/products/fda-510k-k140980-ti-nasal-mask 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140980, TI NASAL MASK, by Respironics, Inc. https://foiadocs.com/products/fda-510k-k142228-heated-eye-pad 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142228, Heated Eye Pad, by Digital Heat Corporation https://foiadocs.com/products/fda-510k-k142940-endoskeleton-tcs-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142940, Endoskeleton TCS System, by Titan Spine, LLC https://foiadocs.com/products/fda-510k-k141142-mammaprint-ffpe 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141142, MAMMAPRINT FFPE, by Agendia https://foiadocs.com/products/fda-510k-k143182-speedicath-compact-male 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143182, Speedicath Compact Male, by Coloplast A/S https://foiadocs.com/products/fda-510k-k141921-hivox-spopad-ems 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141921, HIVOX SPOPAD EMS, by Hivox Biotek, Inc. https://foiadocs.com/products/fda-510k-k133333-uni-npwt-foam-dressing-kit-uni-npwt-foam-dressing-kit-uni-npwt-foam-dressing-kit 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133333, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, by Blue Ocean Medical Product, LLC https://foiadocs.com/products/fda-510k-k142807-anthem-ps-total-knee-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142807, ANTHEM PS Total Knee System, by Smith & Nephew, Inc. https://foiadocs.com/products/fda-510k-k141752-nxstage-system-one 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141752, NXSTAGE SYSTEM ONE, by Nxstage Medical, Inc. https://foiadocs.com/products/fda-510k-k140847-cardiospy-ecg-holter-systems 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140847, CARDIOSPY ECG HOLTER SYSTEMS, by Labtech Kft. https://foiadocs.com/products/fda-510k-k141681-sysmex-xn-series 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141681, SYSMEX XN SERIES, by Sysmex America, Inc. https://foiadocs.com/products/fda-510k-k140382-aeromini-tracheobronchial-stent-technology 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140382, AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY, by Merit Medical Systems, Inc. https://foiadocs.com/products/fda-510k-k133348-stim-probe 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133348, STIM PROBE, by Spes Medica Srl https://foiadocs.com/products/fda-510k-k133997-lg-smarthealth 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133997, LG SMARTHEALTH, by Lg Electronics https://foiadocs.com/products/fda-510k-k142079-stalif-cti-stalif-c 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142079, STALIF CTI, STALIF C, by Centinel Spine, Inc. https://foiadocs.com/products/fda-510k-k142095-renovis-s134-anterior-lumbar-interbody-fusion-alif-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142095, RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM, by Renovis Surgical Technologies, Inc. https://foiadocs.com/products/fda-510k-k142160-logiq-e9-diagnostic-ultrasound-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142160, LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, by GE Healthcare https://foiadocs.com/products/fda-510k-k141894-sharkcore-fine-needle-biopsy-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141894, SHARKCORE FINE NEEDLE BIOPSY SYSTEM, by Covidien, LLC( Formerly Beacon Endoscopic Corp.) https://foiadocs.com/products/fda-510k-k141935-stryker-s2-drill 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141935, STRYKER S2 DRILL, by Stryker Corporation https://foiadocs.com/products/fda-510k-k141405-mobis-ii-st-spinal-implant 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141405, MOBIS II ST SPINAL IMPLANT, by Signus Medizintechnik GmbH https://foiadocs.com/products/fda-510k-k141122-harmonic-scallop-blade-generator-g11 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141122, HARMONIC SCALLOP BLADE, GENERATOR G11, by Ethicon Endo-Surgery, LLC https://foiadocs.com/products/fda-510k-k133983-intra-ox-handheld-tissue-oximeter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133983, INTRA. OX HANDHELD TISSUE OXIMETER, by Vioptix, Inc. https://foiadocs.com/products/fda-510k-k133895-deka-smartxide-laser-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133895, DEKA SMARTXIDE LASER SYSTEM, by El.En S.P.A. https://foiadocs.com/products/fda-510k-k140919-respiconnect-adapter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140919, RESPICONNECT ADAPTER, by Trudell Medical Int'L https://foiadocs.com/products/fda-510k-k132983-ton-95lh-pax-i3d-ortho 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132983, TON-95LH, PAX-I3D ORTHO, by VATECH Co., Ltd. https://foiadocs.com/products/fda-510k-k141371-sonicision-cordless-ultrasonic-dissector 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141371, SONICISION CORDLESS ULTRASONIC DISSECTOR, by Covidien, Formerly Valleylab, A Division of Tyco H https://foiadocs.com/products/fda-510k-k141049-ifuse-implant-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141049, IFUSE IMPLANT SYSTEM, by SI-BONE, Inc. https://foiadocs.com/products/fda-510k-k140903-nuvis-arthroscope 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140903, NUVIS ARTHROSCOPE, by Integrated Endoscopy, Inc. https://foiadocs.com/products/fda-510k-k140336-optimus-fusion-slt-yag-and-yag-slt 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140336, OPTIMUS FUSION: SLT, YAG AND YAG/SLT, by Quantel Medical https://foiadocs.com/products/fda-510k-k141104-truklear-bracket 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141104, TRUKLEAR BRACKET, by Ajw Technology Consultants, Inc. https://foiadocs.com/products/fda-510k-k133598-cardiohelp-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133598, CARDIOHELP SYSTEM, by Maquet Cardiopulmonary, AG https://foiadocs.com/products/fda-510k-k132108-maxio 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132108, MAXIO, by Perfint Healthcare Pvt, Ltd. https://foiadocs.com/products/fda-510k-k133853-viewflex-xtra-ice-catheter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133853, VIEWFLEX XTRA ICE CATHETER, by Irvine Biomedical, Inc., A St. Jude Medical Company https://foiadocs.com/products/fda-510k-k133879-fore-sight-elite-absolute-tissue-oximeter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133879, FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER, by Cas Medical Systems, Inc. https://foiadocs.com/products/fda-510k-k140763-monofilament-polypectomy-snare 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140763, MONOFILAMENT POLYPECTOMY SNARE, by United States Endoscopy https://foiadocs.com/products/fda-510k-k133941-mitek-arthroscopes 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133941, MITEK ARTHROSCOPES, by Medos International SARL https://foiadocs.com/products/fda-510k-k140625-orthosorb-ls 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140625, ORTHOSORB LS, by Biomet, Inc. https://foiadocs.com/products/fda-510k-k133791-ora-0-4mm-s-ora-1-0mm-s-ora-2-0mm-s-ora-3-0mm-s-ora-4-0mm-s 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133791, ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S], by Sterngold Dental, LLC https://foiadocs.com/products/fda-510k-k140194-namic-rcs-syringe 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140194, NAMIC RCS SYRINGE, by Navilyst Medical, Inc. https://foiadocs.com/products/fda-510k-k133705-revolution-ct 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133705, REVOLUTION CT, by Ge Medical Systems, LLC https://foiadocs.com/products/fda-510k-k133923-multi-parameter-mobile-careguide-3100-oximeter-with-tablet 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133923, MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET, by Reflectance Medical, Inc. https://foiadocs.com/products/fda-510k-k131541-flexible-cooagen-nerve-cuff 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131541, FLEXIBLE COOAGEN NERVE CUFF, by Collagen Matrix, Inc. https://foiadocs.com/products/fda-510k-k140043-dynasty-shell-dynasty-a-class-crosslinked-poly-liner-biolox-delta-femoral-head 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140043, DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD, by Microport Orthopedics, Inc. https://foiadocs.com/products/fda-510k-k140131-sub-q-subcutaneous-tissue-infusion-set 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140131, SUB-Q SUBCUTANEOUS TISSUE INFUSION SET, by Emed Technologies Corporation https://foiadocs.com/products/fda-510k-k140106-s128-anterior-lumbar-interbody-fusion-alif-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140106, S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM, by Renovis Surgical Technologies, Inc. https://foiadocs.com/products/fda-510k-k140415-monotex 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140415, MONOTEX, by Riverpoint Medical https://foiadocs.com/products/fda-510k-k140345-the-sherlock-3cg-tip-confirmation-system-tcs 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140345, THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS), by C.R. Bard, Inc. https://foiadocs.com/products/fda-510k-k133764-chlorashield-iv-dressing-with-chg-antimicrobial 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133764, CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL, by Avery Dennison Belgie Bvba https://foiadocs.com/products/fda-510k-k131433-isys-1-u-s-accessory-non-sterile 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131433, ISYS 1 (U.S),ACCESSORY, NON-STERILE, by Isys Medizintechnik GmbH https://foiadocs.com/products/fda-510k-k133715-charlotte-claw-plate-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133715, CHARLOTTE CLAW PLATE SYSTEM, by Wrightmedicaltechnologyinc https://foiadocs.com/products/fda-510k-k133858-tensyn-band 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133858, TENSYN BAND, by Dallen Medical, Inc. https://foiadocs.com/products/fda-510k-k131252-puritan-bennett-980-series-ventilator-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131252, PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM, by Covidien https://foiadocs.com/products/fda-510k-k131260-nmi-dialysis-catheter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131260, NMI DIALYSIS CATHETER, by Navilyst Medical, Inc. https://foiadocs.com/products/fda-510k-k132839-fuse-1c-colonoscopy-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132839, FUSE 1C COLONOSCOPY SYSTEM, by Endochoice, Inc. https://foiadocs.com/products/fda-510k-k133950-activapin-ht-fuse-link-private-labled-for-footmind-inc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133950, ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.), by Bioretec, Ltd. https://foiadocs.com/products/fda-510k-k131799-quicknit 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131799, QUICKNIT, by Microcopy, Div. of Neo-Flo, Inc. https://foiadocs.com/products/fda-510k-k132660-nerve-cuff 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132660, NERVE CUFF, by Cook Biotech Incorporated https://foiadocs.com/products/fda-510k-k133520-hammerlock-2 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133520, HAMMERLOCK 2, by Biomedical Enterprises, Inc. https://foiadocs.com/products/fda-510k-k131447-intuition-tda-tva-parametric-mapping 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131447, INTUITION - TDA, TVA, PARAMETRIC MAPPING, by Terarecon,Inc. https://foiadocs.com/products/fda-510k-k133281-neotract-urolift-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133281, NEOTRACT UROLIFT SYSTEM, by Neotract, Inc. https://foiadocs.com/products/fda-510k-k132429-spectra-optia-apheresis-system-spectra-optia-system-software-spectra-optia-exchange-disposable-set 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132429, SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET, by Terumobct, Inc. https://foiadocs.com/products/fda-510k-k133314-harmonic-focus-shears-adaptive-tissue-technology 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133314, HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY, by Ethicon Endo-Surgery, LLC https://foiadocs.com/products/fda-510k-k132848-piezosurgery-flex 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132848, PIEZOSURGERY FLEX, by Mectron S.P.A. https://foiadocs.com/products/fda-510k-k131897-cv3000-holter-analysis-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131897, CV3000 HOLTER ANALYSIS SYSTEM, by Vales & Hills Biomedical Tech. , Ltd. https://foiadocs.com/products/fda-510k-k130135-dana-reusable-bi-test-pack 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130135, DANA REUSABLE BI TEST PACK, by Dana Products, Inc. https://foiadocs.com/products/fda-510k-k131482-sofia-distal-access-catheter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131482, SOFIA DISTAL ACCESS CATHETER, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k132750-illumina-miseqdx-cystic-fibrosis-clinical-sequencing-assay 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132750, ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY, by Illumina, Inc. https://foiadocs.com/products/fda-510k-k122061-k-y-brand-liquibeads 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122061, K-Y BRAND LIQUIBEADS, by Johnson & Johnson Healthcare Products https://foiadocs.com/products/fda-510k-k130357-superdimension-triple-needle-cytology-brush 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130357, SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH, by Covidien, LLC https://foiadocs.com/products/fda-510k-k124041-nbm-200mp 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K124041, NBM-200MP, by Orsense, Ltd. https://foiadocs.com/products/fda-510k-k131991-endochoice-hot-biopsy-forceps 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131991, ENDOCHOICE HOT BIOPSY FORCEPS, by Endochoice, Inc. https://foiadocs.com/products/fda-510k-k131337-balanced-knee-system-high-flex-vitamin-e-ps-tibial-insert-and-patella 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131337, BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA, by Ortho Development Corp. https://foiadocs.com/products/fda-510k-k132560-pcp-usb-stethoscope 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132560, PCP-USB STETHOSCOPE, by Rnk Products, Inc. https://foiadocs.com/products/fda-510k-k131684-bioloxr-delta-ceramic-heads 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131684, BIOLOX(R) DELTA CERAMIC HEADS, by Biomet, Inc. https://foiadocs.com/products/fda-510k-k132667-synergy-odm 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132667, SYNERGY ODM, by Topcon Medical Systems, Inc. https://foiadocs.com/products/fda-510k-k132317-microplex-coil-system-mcs-vfc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132317, MICROPLEX COIL SYSTEM (MCS), VFC, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k131122-s128-anterior-lumbar-interbody-fusion-alif-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131122, S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM, by Renovis Surgical Technologies, LLC https://foiadocs.com/products/fda-510k-k130341-strawberry-strawberry-cream 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130341, STRAWBERRY, STRAWBERRY & CREAM, by Laser Lipo Limited https://foiadocs.com/products/fda-510k-k124044-aloe-cadabra-lubricant-aloe-cadabra-flavored-scented-lubricants 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K124044, ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS, by Seven Oaks Ranch, Inc. https://foiadocs.com/products/fda-510k-k131197-edgewise-ceramic-brackets-roth-ceramic-brackets 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131197, EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS, by Dental Morelli https://foiadocs.com/products/fda-510k-k130887-s4c-navigation-instruments 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130887, S4C NAVIGATION INSTRUMENTS, by Aesculap Implant System, Inc. https://foiadocs.com/products/fda-510k-k122337-ovusense 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122337, OVUSENSE, by Fertility Focus, Ltd. https://foiadocs.com/products/fda-510k-k130126-signature-personalized-patient-care-system-glenoid-guide-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130126, SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM, by Biomet, Inc. https://foiadocs.com/products/fda-510k-k130702-airsonett-air-4 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130702, AIRSONETT AIR-4, by Airsonett AB https://foiadocs.com/products/fda-510k-k131203-ihealth-cloud 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131203, IHEALTH CLOUD, by Andon Health Co, Ltd. https://foiadocs.com/products/fda-510k-k131434-vs3-stereoscopic-high-definition-vision-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131434, VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM, by Visionsense, Ltd. https://foiadocs.com/products/fda-510k-k123881-heartsine-samaritan-pad-350p 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123881, HEARTSINE SAMARITAN PAD 350P, by Heartsine Technologies, Inc. https://foiadocs.com/products/fda-510k-k131283-prophecy-infinity-preoperative-navigation-alignment-guides 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131283, PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES, by Wrightmedicaltechnologyinc https://foiadocs.com/products/fda-510k-k123427-nirvana-d-personal-lubricant-tbd 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123427, NIRVANA D PERSONAL LUBRICANT (TBD), by Church & Dwight Co., Inc. https://foiadocs.com/products/fda-510k-k131131-e-g-scantm-ii-esophagoscope-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131131, E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM, by Intromedic Co., Ltd. https://foiadocs.com/products/fda-510k-k131153-evenflo-advanced-double-electric-breast-pump 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131153, EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP, by Evenflo Feeding Incorporated https://foiadocs.com/products/fda-510k-k130025-sonendo-endotherapy-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130025, SONENDO ENDOTHERAPY SYSTEM, by Sonendo, Inc. https://foiadocs.com/products/fda-510k-k130185-4web-osteotomy-bone-wedge 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130185, 4WEB OSTEOTOMY BONE WEDGE, by 4-Web, Inc. https://foiadocs.com/products/fda-510k-k130446-fastbraces-ceramic-brackets 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130446, FASTBRACES CERAMIC BRACKETS, by Orthodontic Design and Production, Inc. https://foiadocs.com/products/fda-510k-k123481-aquacel-ag-foam-hydrofiber-foam-dressing-with-silver-adhesive-and-non-adhesive 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123481, AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE, by Convatec, Inc. https://foiadocs.com/products/fda-510k-k130288-stealth-monitor-stealth-docking-cable-stealth-display-and-storage-device 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130288, STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE, by Cardiac Insight, Inc. https://foiadocs.com/products/fda-510k-k130524-breathid-hp-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130524, BREATHID HP SYSTEM, by Exalenz Bioscience , Ltd. https://foiadocs.com/products/fda-510k-k130077-remstar-se 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130077, REMSTAR SE, by Respironics, Inc. https://foiadocs.com/products/fda-510k-k123542-pascal-synthesis-532nm-577nm-opthalmic-laser 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123542, PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER, by Topcon Medical Laser Systems, Inc. https://foiadocs.com/products/fda-510k-k130899-biolox-delta-ceramic-femoral-heads 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130899, BIOLOX DELTA CERAMIC FEMORAL HEADS, by Zimmer GmbH https://foiadocs.com/products/fda-510k-k120250-fibrillar-collagen-wound-dressing 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120250, FIBRILLAR COLLAGEN WOUND DRESSING, by Collafirm, LLC https://foiadocs.com/products/fda-510k-k123909-aesculap-cespace-xp 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123909, AESCULAP CESPACE XP, by Aesculap Implant System, Inc. https://foiadocs.com/products/fda-510k-k123014-litecure-therapy-system-model-lts-1500 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123014, LITECURE THERAPY SYSTEM MODEL LTS-1500, by Litecure, LLC https://foiadocs.com/products/fda-510k-k130164-fiberlase-endure-co2-fiber 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130164, FIBERLASE ENDURE CO2 FIBER, by Lumenis, Ltd. https://foiadocs.com/products/fda-510k-k123169-oralid 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123169, ORALID, by Forward Science, LLC https://foiadocs.com/products/fda-510k-k123862-zimmer-nexel-total-elbow 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123862, ZIMMER NEXEL TOTAL ELBOW, by Zimmer, Inc. https://foiadocs.com/products/fda-510k-k130131-edrain-chest-drainage-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130131, EDRAIN CHEST DRAINAGE SYSTEM, by Atrium Medical Corp. https://foiadocs.com/products/fda-510k-k123361-esotest-esophageal-temperature-probe-and-temperature-monitoring-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123361, ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM, by Fiab Spa https://foiadocs.com/products/fda-510k-k122520-digital-thermomter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122520, DIGITAL THERMOMTER, by Taidoc Technology Corporation https://foiadocs.com/products/fda-510k-k122550-ics-impulse 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122550, ICS IMPULSE, by Gn Otometrics https://foiadocs.com/products/fda-510k-k121326-lantos-3d-ear-scanner 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121326, LANTOS 3D EAR SCANNER, by Lantos Technologies https://foiadocs.com/products/fda-510k-k123237-zerona-2-0-laser 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123237, ZERONA 2.0 LASER, by Erchonia Corporation https://foiadocs.com/products/fda-510k-k113246-ocs-b 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K113246, OCS-B, by Nibec Company, Limited https://foiadocs.com/products/fda-510k-k121959-evis-exera-iii-video-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121959, EVIS EXERA III VIDEO SYSTEM, by Olympus Medical Systems Corp. https://foiadocs.com/products/fda-510k-k123223-ec-single-use-polypectomy-snare 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123223, EC SINGLE USE, POLYPECTOMY SNARE, by Endochoice, Inc. https://foiadocs.com/products/fda-510k-k123396-i-flex-by-tcs 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123396, I.FLEX BY TCS, by Thermoplastic Comfort Systems, Inc. https://foiadocs.com/products/fda-510k-k123213-bd-phaseal-closed-system-transfer-device 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123213, BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE, by Becton, Dickinson & CO https://foiadocs.com/products/fda-510k-k100695-colladental-barrier 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100695, COLLADENTAL BARRIER, by Collamatrix, Inc. https://foiadocs.com/products/fda-510k-k123729-versarate-flow-rate-controler 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123729, VERSARATE FLOW RATE CONTROLER, by Emed Technologies Corporation https://foiadocs.com/products/fda-510k-k123564-logiq-e9-diagnostic-ultrasound-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123564, LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, by GE Healthcare https://foiadocs.com/products/fda-510k-k122753-empower-clear 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122753, EMPOWER CLEAR, by American Orthodontics https://foiadocs.com/products/fda-510k-k122248-igrow-ii-hair-growth-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122248, IGROW II HAIR GROWTH SYSTEM, by Apira Science, Inc. https://foiadocs.com/products/fda-510k-k122762-acculis-accu21-pmta-microwave-tissue-ablation-applicator 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122762, ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR, by Microsulis Medical Limited https://foiadocs.com/products/fda-510k-k122356-alivecor-heart-monitor-for-iphone 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122356, ALIVECOR HEART MONITOR FOR IPHONE, by AliveCor, Inc. https://foiadocs.com/products/fda-510k-k113728-surfuse-gel-and-putty-exfuse-gel-and-putty 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K113728, SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY, by Hans Biomed Corp. https://foiadocs.com/products/fda-510k-k121213-vitreaadvanced 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121213, VITREAADVANCED, by Vital Images, Inc. https://foiadocs.com/products/fda-510k-k120406-zoll-fully-automatic-aed-plus 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120406, ZOLL FULLY AUTOMATIC AED PLUS, by Zoll Medical Corporation, World Wide Headquarters https://foiadocs.com/products/fda-510k-k122924-cre-fixed-wire-ballon-dilation-catheter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122924, CRE FIXED WIRE BALLON DILATION CATHETER, by Boston Scientific Corp https://foiadocs.com/products/fda-510k-k121754-blue-sui-sling 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121754, BLUE SUI SLING, by Boston Scientific Corp https://foiadocs.com/products/fda-510k-k120306-rapicide-opa-28 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120306, RAPICIDE OPA-28, by Minntech Corp. https://foiadocs.com/products/fda-510k-k120087-exspiron 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120087, EXSPIRON, by Respiratory Motion, Inc. https://foiadocs.com/products/fda-510k-k113836-benehold-chg-transparent-film-dressing-10x12cm-8-5x12cm-6-5x7-cm 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K113836, BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM), by Avery Dennison Belgie Bvba https://foiadocs.com/products/fda-510k-k113282-cerasorb-dental-ceradorb-m-dental-cerasorb-perio 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K113282, CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO, by Riemser Arzeimittel AG https://foiadocs.com/products/fda-510k-k122413-patient-positioning-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122413, PATIENT POSITIONING SYSTEM, by Forte Automation Systems, Inc. https://foiadocs.com/products/fda-510k-k120766-endoscopic-diagnostic-treatment-system-modification 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120766, ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION), by Prosurg, Inc. https://foiadocs.com/products/fda-510k-k113666-xia-3-spinal-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K113666, XIA 3 SPINAL SYSTEM, by Stryker Spine https://foiadocs.com/products/fda-510k-k121695-erchonia-zerona 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121695, ERCHONIA ZERONA, by Erchonia Corporation https://foiadocs.com/products/fda-510k-k122086-thermal-ligating-shears 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122086, THERMAL LIGATING SHEARS, by Microline Surgical, Inc. https://foiadocs.com/products/fda-510k-k120562-performax-pediatric-ee-total-face-mask 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120562, PERFORMAX PEDIATRIC EE TOTAL FACE MASK, by Respironics, Inc. https://foiadocs.com/products/fda-510k-k121074-scenium-2-0 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121074, SCENIUM 2.0, by Siemens Medical Solutions USA, Inc. https://foiadocs.com/products/fda-510k-k111862-viewray-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K111862, VIEWRAY SYSTEM, by Viewray, Incorporated https://foiadocs.com/products/fda-510k-k120216-genosyl-mv-1000 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120216, GENOSYL MV-1000, by Geno, LLC https://foiadocs.com/products/fda-510k-k120257-mls-zerona-ad 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120257, MLS, ZERONA-AD, by Erchonia Medical, Inc. https://foiadocs.com/products/fda-510k-k120298-cps-excel-mediguide-enabled-guidewire 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120298, CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE, by St. Jude Medical, Cardiac Rhythm Management Divisi https://foiadocs.com/products/fda-510k-k121166-wondfo-multi-drug-urine-test-cup-wondfo-multi-drug-urine-test-panel 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121166, WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL, by Guangzhou Wondfo Biotech Co., Ltd. https://foiadocs.com/products/fda-510k-k112549-iv-clear-antimicrobial-clear-silicone-adhesive-dressing-with-chlorhexidine-and-silver 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K112549, IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER, by Covalontechnologies, Inc. https://foiadocs.com/products/fda-510k-k112909-ocd04-3-hydrogen-peroxide-cleaning-and-disinfecting-soultion 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K112909, OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION, by Bausch & Lomb, Inc. https://foiadocs.com/products/fda-510k-k111250-dry-mouth-mouthwash 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K111250, DRY MOUTH MOUTHWASH, by Dr. Fresh, Inc. https://foiadocs.com/products/fda-510k-k113796-solitaire-c-cervical-spacer-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K113796, SOLITAIRE-C CERVICAL SPACER SYSTEM, by Ebi, LLC https://foiadocs.com/products/fda-510k-k120187-multi-modality-image-fusion 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120187, MULTI-MODALITY IMAGE FUSION, by Igt, LLC Dba Eigen https://foiadocs.com/products/fda-510k-k120238-rtvue-xr-oct 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120238, RTVUE XR OCT, by Optovue, Inc. https://foiadocs.com/products/fda-510k-k112422-crag-lateral-flow-assay-lfa 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K112422, CRAG LATERAL FLOW ASSAY (LFA), by Immuno-Mycologics, Inc. https://foiadocs.com/products/fda-510k-k120593-myosure-control-unit 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120593, MYOSURE CONTROL UNIT, by Hologic, Inc. https://foiadocs.com/products/fda-510k-k113872-the-oncontrol-bone-access-and-bone-biopsy-system-by-vidacare 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K113872, THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE, by Vidacare Corporation https://foiadocs.com/products/fda-510k-k120301-mediguide-technology 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120301, MEDIGUIDE TECHNOLOGY, by St. Jude Medical, Mediguide Navigation Systems https://foiadocs.com/products/fda-510k-k110179-incontrol 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110179, INCONTROL, by Incontrol Medical, LLC https://foiadocs.com/products/fda-510k-k113259-notouch-breastscan 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K113259, NOTOUCH BREASTSCAN, by Ue Lifesciences, Inc. https://foiadocs.com/products/fda-510k-k113663-sonixtablet-ultrasound-scanner 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K113663, SONIXTABLET ULTRASOUND SCANNER, by Ultrasonix Medical Corporation https://foiadocs.com/products/fda-510k-k113294-smith-nephew-healicoil-pk-suture-anchor 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K113294, SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR, by Smith & Nephew, Inc. https://foiadocs.com/products/fda-510k-k110888-absolute-white-light 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110888, ABSOLUTE WHITE LIGHT, by Dr. Fresh, Inc. https://foiadocs.com/products/fda-510k-k111717-electro-gel 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K111717, ELECTRO-GEL, by Electro-Cap Intl., Inc. https://foiadocs.com/products/fda-510k-k112437-arthrex-fracture-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K112437, ARTHREX FRACTURE SYSTEM, by Arthrex, Inc. https://foiadocs.com/products/fda-510k-k113500-canady-vieira-hybrid-plasma-scalpel 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K113500, CANADY VIEIRA HYBRID PLASMA SCALPEL, by Us Medical Innovations, LLC https://foiadocs.com/products/fda-510k-k113201-narval-cc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K113201, NARVAL CC, by Resmed Sas https://foiadocs.com/products/fda-510k-k111773-renu-medical-reprocessed-oximax-sensors-adult-pediatric-infant-and-neonate 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K111773, RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE, by Renu Medical, Inc. https://foiadocs.com/products/fda-510k-k112205-snorerx-9-0 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K112205, SNORERX 9.0, by Consumer Health Products, Inc. https://foiadocs.com/products/fda-510k-k111010-spiderfx-embolic-protection-device 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K111010, SPIDERFX EMBOLIC PROTECTION DEVICE, by Ev3, Inc. https://foiadocs.com/products/fda-510k-k112844-rehastim-2-rehamove-2 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K112844, REHASTIM 2, REHAMOVE 2, by Hasomed GmbH https://foiadocs.com/products/fda-510k-k112249-healix-knotlesstm-anchor 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K112249, HEALIX KNOTLESS(TM) ANCHOR, by Depuy Mitek, A Johnson & Johnson Company https://foiadocs.com/products/fda-510k-k112226-hydrocoil-embolic-system-hes 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K112226, HYDROCOIL EMBOLIC SYSTEM (HES), by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k111763-pathassist-light-fiber 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K111763, PATHASSIST LIGHT FIBER, by Entellus Medical, Inc. https://foiadocs.com/products/fda-510k-k103648-collagen-powder 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K103648, COLLAGEN POWDER, by Innocoll Pharmaceuticals, Ltd. https://foiadocs.com/products/fda-510k-k112376-s-cath-esophageal-temperature-probe-and-temperature-monitoring-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K112376, S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM, by Circa Scientific, LLC https://foiadocs.com/products/fda-510k-k110301-silkn-fx 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110301, SILK'N FX, by Home Skinovations , Ltd. https://foiadocs.com/products/fda-510k-k111508-trident-specimen-radiography-system-model-rc-tri-00001 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K111508, TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001, by Hologic, Inc. https://foiadocs.com/products/fda-510k-k110397-trumatch-personalized-solutions 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110397, TRUMATCH PERSONALIZED SOLUTIONS, by DePuy Orthopaedics, Inc. https://foiadocs.com/products/fda-510k-k110869-cara 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110869, CARA, by Diagnos, Inc. https://foiadocs.com/products/fda-510k-k111226-endoscout-tracking-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K111226, ENDOSCOUT TRACKING SYSTEM, by Robin Medical, Inc. https://foiadocs.com/products/fda-510k-k110516-connex-vital-signs-monitor-6000-series 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110516, CONNEX VITAL SIGNS MONITOR 6000 SERIES, by Welch Allyn, Inc. https://foiadocs.com/products/fda-510k-k110097-acclarent-cyclops-multi-angle-endoscope 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110097, ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE, by Acclarent, Inc. https://foiadocs.com/products/fda-510k-k110641-fujirebio-diagnostics-vitamin-d-control 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110641, FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL, by Fujirebio Diagnostics,Inc. https://foiadocs.com/products/fda-510k-k103692-sugiquest-airsealoptical-trocar-cannula-system-with-integrated-insufflator-dpis-2000 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K103692, SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000, by Surgiquest, Inc. https://foiadocs.com/products/fda-510k-k102199-otomag-bone-conduction-hearing-system-model-alpha-1-s-and-alpha-1-m 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K102199, OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M), by Sophono, Inc. https://foiadocs.com/products/fda-510k-k110335-ceramic-brackets 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110335, CERAMIC BRACKETS, by Ortho Organizers, Inc. https://foiadocs.com/products/fda-510k-k103473-zoll-rescuenet-epcr-model-rescuenet-epcr 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K103473, ZOLL RESCUENET EPCR MODEL RESCUENET EPCR, by ZOLL Medical Corporation https://foiadocs.com/products/fda-510k-k110253-reusable-test-pack-for-dana-emulating-indicators 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110253, REUSABLE TEST PACK FOR DANA EMULATING INDICATORS, by Dana Products, Inc. https://foiadocs.com/products/fda-510k-k110582-valo-cordless 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110582, VALO CORDLESS, by Ultradent Products, Inc. https://foiadocs.com/products/fda-510k-k110542-consensus-biolox-delta-ceramic-femoral-head 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110542, CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD, by Consensus Orthopedics, Inc. https://foiadocs.com/products/fda-510k-k110699-ligamax-5 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110699, LIGAMAX 5, by Ethicon Endo-Sugery, LLC https://foiadocs.com/products/fda-510k-k101458-lina-xcise-model-mor-1515 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K101458, LINA XCISE MODEL MOR-1515, by Lina Medical Aps https://foiadocs.com/products/fda-510k-k103480-thoracic-vcar 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K103480, THORACIC VCAR, by Ge Medical Systems, LLC https://foiadocs.com/products/fda-510k-k103120-corin-biolox-delta-femoral-heads 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K103120, CORIN BIOLOX DELTA FEMORAL HEADS, by Corin USA https://foiadocs.com/products/fda-510k-k102803-clarity-advanced-ceramic-brackets 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K102803, CLARITY ADVANCED CERAMIC BRACKETS, by 3M Unitek Corporation https://foiadocs.com/products/fda-510k-k091207-surgicraft-lockdown-acromioclavicular-ac-device 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K091207, SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE, by Surgicraft , Ltd. https://foiadocs.com/products/fda-510k-k093745-one-touch-verio-blood-glucose-monitoring-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093745, ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM, by Lifescan, Inc. https://foiadocs.com/products/fda-510k-k102470-lugasure-curved-small-jaw-open-sealer-divider 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K102470, LUGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER, by Covidien, Formerly Valleylab, https://foiadocs.com/products/fda-510k-k103785-mobile-mim 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K103785, MOBILE MIM, by Mim Software, Inc. https://foiadocs.com/products/fda-510k-k101801-monica-an24 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K101801, MONICA AN24, by Monica Healthcare https://foiadocs.com/products/fda-510k-k100927-surgiaid 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100927, SURGIAID, by Maxigen Biotech, Inc. https://foiadocs.com/products/fda-510k-k101454-mammaprint 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K101454, MAMMAPRINT, by Agendia https://foiadocs.com/products/fda-510k-k101346-gc-oral-moisturizing-gel 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K101346, GC ORAL MOISTURIZING GEL, by GC America, Inc. https://foiadocs.com/products/fda-510k-k102722-norian-drillable-inject-norian-drillable-fast-set-putty 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K102722, NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY, by Synthes USA Products, LLC https://foiadocs.com/products/fda-510k-k102893-pcp-pc-stethoscope 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K102893, PCP/PC STETHOSCOPE, by Rnk Products, Inc. https://foiadocs.com/products/fda-510k-k102915-viewray-treatment-planning-and-delivery-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K102915, VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM, by Viewray, Incorporated https://foiadocs.com/products/fda-510k-k100577-acclarent-cyclops-multi-angle-endoscope 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100577, ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE, by Acclarent, Inc. https://foiadocs.com/products/fda-510k-k102761-dana-reusable-test-pack-for-steam-sterilization 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K102761, DANA REUSABLE TEST PACK FOR STEAM STERILIZATION, by Dana Products, Inc. https://foiadocs.com/products/fda-510k-k093565-pleuraflow-catheter-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093565, PLEURAFLOW CATHETER SYSTEM, by Clear Catheter Systems https://foiadocs.com/products/fda-510k-k102217-system-1e-chemical-indicator 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K102217, SYSTEM 1E CHEMICAL INDICATOR, by STERIS Corporation https://foiadocs.com/products/fda-510k-k101104-remin-pro 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K101104, REMIN PRO, by Voco GmbH https://foiadocs.com/products/fda-510k-k102604-i-logic-inreach-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K102604, I-LOGIC INREACH SYSTEM, by Superdimension, Ltd. https://foiadocs.com/products/fda-510k-k101477-biotene-dry-mouth-mouthwash-biotene-pbf-dry-mouth-mouthwash 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K101477, BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH, by Glaxosmithkline Consumer Healthcare (Gskch) https://foiadocs.com/products/fda-510k-k102219-socorro-smi-tunnel-release-device 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K102219, SOCORRO SMI TUNNEL RELEASE DEVICE, by Socorro Medical, Inc. https://foiadocs.com/products/fda-510k-k100787-renasys-f-ab-abdominal-wound-dressing-kit 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100787, RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT, by Smith & Nephew, Inc. https://foiadocs.com/products/fda-510k-k101834-3m-littmann-scope-to-scope-software-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K101834, 3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM, by 3M Company https://foiadocs.com/products/fda-510k-k101810-3dhjd-camera-system-model 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K101810, 3DHJD CAMERA SYSTEM MODEL, by Vision Systems Group, A Division of Viking Systems https://foiadocs.com/products/fda-510k-k101561-tx1-tissue-removal-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K101561, TX1 TISSUE REMOVAL SYSTEM, by American Optisurgical, Inc. https://foiadocs.com/products/fda-510k-k101386-vigilant-eeg-monitor-model-vigilant-2-0 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K101386, VIGILANT EEG MONITOR MODEL VIGILANT 2.0, by Infinite Biomedical Technologies, LLC https://foiadocs.com/products/fda-510k-k093775-evguide-tip-location-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093775, EVGUIDE TIP LOCATION SYSTEM, by Romedex International Srl https://foiadocs.com/products/fda-510k-k100441-xiniwave-model-xw-18 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100441, XINIWAVE, MODEL XW-18, by International Trade Group, Inc. https://foiadocs.com/products/fda-510k-k100644-optos-limited-panoramic-200caf 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100644, OPTOS LIMITED PANORAMIC 200CAF, by Optos Plc. https://foiadocs.com/products/fda-510k-k100902-aedistm 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100902, AEDIS(TM), by Embed Technology, LLC https://foiadocs.com/products/fda-510k-k101451-apex-module-hip-system-biolox-delta-femoral-head 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K101451, APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD, by Omni Life Science, Inc. https://foiadocs.com/products/fda-510k-k093810-bf-navi 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093810, BF-NAVI, by Kgt, Inc. https://foiadocs.com/products/fda-510k-k100099-oral-enteral-syringes 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100099, ORAL/ENTERAL SYRINGES, by Philips Children'S Medical Ventures https://foiadocs.com/products/fda-510k-k100349-vistakon-narafilcon-b-contact-lens-visibility-tinted-with-uv-blocker 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100349, VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER, by Johnson & Johnson Vision Care, Inc. https://foiadocs.com/products/fda-510k-k100412-biolox-delta-ceramic-femoral-heads 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100412, BIOLOX DELTA CERAMIC FEMORAL HEADS, by Smith & Nephew, Inc. https://foiadocs.com/products/fda-510k-k094018-lc-bead-microspheres-bead-block-compressible-microspheres 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K094018, LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES, by Biocompatibles UK Limited https://foiadocs.com/products/fda-510k-k093806-myknee-cutting-blocks 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093806, MYKNEE CUTTING BLOCKS, by Medacta International S.A. https://foiadocs.com/products/fda-510k-k092944-dana-reusable-test-pack-for-steam-sterilization 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092944, DANA REUSABLE TEST PACK FOR STEAM STERILIZATION, by Dana Products, Inc. https://foiadocs.com/products/fda-510k-k093930-didget-world-reports 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093930, DIDGET WORLD REPORTS, by Bayer Healthcare, LLC https://foiadocs.com/products/fda-510k-k093624-optiscan-model-optiscan-ceis 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093624, OPTISCAN MODEL OPTISCAN CEIS, by Optiscan Pty. , Ltd. https://foiadocs.com/products/fda-510k-k093677-stryker-arthroscope 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093677, STRYKER ARTHROSCOPE, by Stryker Endoscopy https://foiadocs.com/products/fda-510k-k091496-mep-90-hair-growth-stimulation-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K091496, MEP-90 HAIR GROWTH STIMULATION SYSTEM, by Midwest Rf, LLC https://foiadocs.com/products/fda-510k-k091283-capillarys-neonat-hb-pn-2006 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K091283, CAPILLARYS NEONAT HB (PN 2006), by Sebia https://foiadocs.com/products/fda-510k-k091757-otc-tens-for-arm-and-leg-pain-relief-model-wl-2407 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K091757, OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407, by Well-Life Healthcare Limited https://foiadocs.com/products/fda-510k-k092224-tigr-surgical-mesh-model-wk-6 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092224, TIGR SURGICAL MESH , MODEL WK-6, by Novus Scientific Pte, Ltd. https://foiadocs.com/products/fda-510k-k082586-lightwave-professional-deluxe 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082586, LIGHTWAVE PROFESSIONAL DELUXE, by Lightwave Technologies, LLC https://foiadocs.com/products/fda-510k-k090820-tria-hair-removal-laser-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K090820, TRIA HAIR REMOVAL LASER SYSTEM, by Spectragenics, Inc. https://foiadocs.com/products/fda-510k-k093549-44mm-e1-acetabular-liner-with-44mm-biolox-delta-option-ceramic-head-or-44mm-m-a-magnum 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093549, 44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM, by Biomet Manufacturing Corp https://foiadocs.com/products/fda-510k-k081092-modification-to-mammaprint 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K081092, MODIFICATION TO MAMMAPRINT, by Agendia https://foiadocs.com/products/fda-510k-k082588-gammaloc-system-model-03-00001 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082588, GAMMALOC SYSTEM, MODEL 03-00001, by Dilon Technologies, LLC https://foiadocs.com/products/fda-510k-k091051-bollard-miniplate-skeletal-anchorage-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K091051, BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM, by Tita-Link https://foiadocs.com/products/fda-510k-k091457-nexstim-eximia-navigated-brain-stimulation-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K091457, NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM, by Nexstim OY https://foiadocs.com/products/fda-510k-k092090-erbelift-hand-pump-and-flexible-probe 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092090, ERBELIFT HAND PUMP AND FLEXIBLE PROBE, by Byrne Medical, Inc. https://foiadocs.com/products/fda-510k-k092150-cobalt-mv-with-gentamicin-aka-cobalt-g-mv-bone-cement 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092150, COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT, by Biomet, Inc. https://foiadocs.com/products/fda-510k-k091499-medeor-matrix-models-30010-xx-hydrated-30020-xx-dry 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K091499, MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY), by Kensey Nash Corp. https://foiadocs.com/products/fda-510k-k091781-guided-medical-positioning-system-gmps 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K091781, GUIDED MEDICAL POSITIONING SYSTEM (GMPS), by Mediguide, Ltd. https://foiadocs.com/products/fda-510k-k091135-rutter-supra-stomal-stents 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K091135, RUTTER SUPRA STOMAL STENTS, by Boston Medical Products, Inc. https://foiadocs.com/products/fda-510k-k092365-inreach-system-model-aas00161-02 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092365, INREACH SYSTEM, MODEL AAS00161-02, by Superdimension, Ltd. https://foiadocs.com/products/fda-510k-k082391-primaeva-medical-renesis-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082391, PRIMAEVA MEDICAL RENESIS SYSTEM, by Primaeva Medical, Inc. https://foiadocs.com/products/fda-510k-k091633-tephaflex-surgical-film 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K091633, TEPHAFLEX SURGICAL FILM, by Tepha, Inc. https://foiadocs.com/products/fda-510k-k083707-arthrex-dual-wave-arthroscopy-fluid-management-device 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K083707, ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE, by Arthrex, Inc. https://foiadocs.com/products/fda-510k-k090224-fortex-pedicle-screw-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K090224, FORTEX PEDICLE SCREW SYSTEM, by X-Spine Systems, Inc. https://foiadocs.com/products/fda-510k-k091760-dermaport-ported-vascular-access-system-pvas 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K091760, DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS), by Dermaport, Inc. https://foiadocs.com/products/fda-510k-k083903-3m-littmann-electronic-stethoscope-model-3200 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K083903, 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200, by 3M Company https://foiadocs.com/products/fda-510k-k091641-hydrocoil-embolic-system-hydrosoft-and-microplex-coil-system-hypersoft 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K091641, HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT), by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k082367-infant-sleep-beanie 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082367, INFANT SLEEP BEANIE, by Life Innovations, LLC https://foiadocs.com/products/fda-510k-k083716-first-response-early-result-pregnancy-test-otc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K083716, FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC), by Church & Dwight Co., Inc. https://foiadocs.com/products/fda-510k-k090037-medicalgorithmics-real-time-ecg-monitor-and-arrhythmia-detector-model-pocketecg 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K090037, MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG, by Medicalgorithmics SP Z.O.O. https://foiadocs.com/products/fda-510k-k090094-zeltiq-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K090094, ZELTIQ SYSTEM, by Zeltiq Aesthetics https://foiadocs.com/products/fda-510k-k090413-a1cnow-10-test-kit-professional-use-model-3024-a1cnow-20-test-kit-professional-use-model-3021-a1cnow-self-chec 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K090413, A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC, by Bayer Healthcare, LLC https://foiadocs.com/products/fda-510k-k090244-swift-fx 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K090244, SWIFT FX, by Resmed, Ltd. https://foiadocs.com/products/fda-510k-k082227-minicap-hemoglobine-kit-model-2207-2227 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082227, MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227, by Sebia https://foiadocs.com/products/fda-510k-k062187-betachek-glucose-test 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062187, BETACHEK GLUCOSE TEST, by National Diagnostic Products https://foiadocs.com/products/fda-510k-k082819-dermatologic-treatment-system-dts-g2 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082819, DERMATOLOGIC TREATMENT SYSTEM (DTS) G2, by Miramar Labs, Inc. https://foiadocs.com/products/fda-510k-k083802-sonotip-ii-25-gauge-ultrasound-needle-system-models-gus-01-18-025-and-gus-01-27-025 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K083802, SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025, by Medi-Globe Corporation https://foiadocs.com/products/fda-510k-k083763-zeus-ct-picc-4-fr-and-5-fr-single-and-dual-lumen 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K083763, ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN, by R4 Vascular, Inc. https://foiadocs.com/products/fda-510k-k083762-biolox-delta-ceramic-femoral-heads 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K083762, BIOLOX DELTA CERAMIC FEMORAL HEADS, by Smith & Nephew, Inc. https://foiadocs.com/products/fda-510k-k082623-visix-imaging 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082623, VISIX IMAGING, by Televere Systems https://foiadocs.com/products/fda-510k-k083691-bonevue 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K083691, BONEVUE, by Micromri, Inc. https://foiadocs.com/products/fda-510k-k082996-biolox-delta-option-ceramic-heads 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082996, BIOLOX DELTA OPTION CERAMIC HEADS, by Biomet, Inc. https://foiadocs.com/products/fda-510k-k083839-avaulta-solo-synthetic-support-system-avaulta-plus-biosynthetic-support-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K083839, AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM, by C.R. Bard, Inc. https://foiadocs.com/products/fda-510k-k083091-lc-bead-microspheres-bead-block-compressible-microspheres 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K083091, LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES, by Biocompatibles UK Limited https://foiadocs.com/products/fda-510k-k081960-invisalign-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K081960, INVISALIGN SYSTEM, by Align Technology https://foiadocs.com/products/fda-510k-k082385-chaperon-guiding-catheter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082385, CHAPERON GUIDING CATHETER, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k082384-hav-lok-bunion-correction-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082384, HAV-LOK BUNION CORRECTION SYSTEM, by Instratek, Inc. https://foiadocs.com/products/fda-510k-k080595-cellavision-dm96-with-the-body-fluid-application 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080595, CELLAVISION DM96 WITH THE BODY FLUID APPLICATION, by CellaVision AB https://foiadocs.com/products/fda-510k-k082423-no-no-skin 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082423, NO!NO! SKIN, by Radiancy (Israel) , Ltd. https://foiadocs.com/products/fda-510k-k082844-biolox-delta-ceramic-femoral-head-biolox-delta-ceramic-femoral-head-offset-sleeve 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082844, BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE, by Encore Medical L.P. https://foiadocs.com/products/fda-510k-k082991-biolox-delta-ceramic-femoral-head 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082991, BIOLOX DELTA CERAMIC FEMORAL HEAD, by Aesculap Implant Systems, Inc. https://foiadocs.com/products/fda-510k-k081981-lang-dental-acrylic-primer 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K081981, LANG DENTAL ACRYLIC PRIMER, by Lang Dental Mfg. Co., Inc. https://foiadocs.com/products/fda-510k-k080591-tanda-skincare-system-model-ptscs 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080591, TANDA SKINCARE SYSTEM, MODEL: PTSCS, by Pharos Life Corporation https://foiadocs.com/products/fda-510k-k080613-clear-vu-system-models-cvl-01-1000-cvl-01-1030-cvl-01-1045 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080613, CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045, by Minimally Invasive Devices, LLC https://foiadocs.com/products/fda-510k-k082720-tracheal-intubation-fibervideoscope-models-lf-y0004-and-lf-y0005 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082720, TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005, by Olympus Medical Systems Corporation https://foiadocs.com/products/fda-510k-k082870-vti-intraoperative-doppler-systems 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082870, VTI INTRAOPERATIVE DOPPLER SYSTEMS, by Vascular Technology Incorporated https://foiadocs.com/products/fda-510k-k081791-e-z-clean-electrosurgical-electrode 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K081791, E-Z CLEAN ELECTROSURGICAL ELECTRODE, by Megadyne Medical Products, Inc. https://foiadocs.com/products/fda-510k-k080275-npd-1000-negative-pressure-wound-therapy-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080275, NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM, by Iasis Medical, Inc. https://foiadocs.com/products/fda-510k-k082386-inreach-planning-laptop 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082386, INREACH PLANNING LAPTOP, by Superdimension, Ltd. https://foiadocs.com/products/fda-510k-k080795-ultra-surgical-gown-fluid-barrier-surgical-gown 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080795, ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN, by Kimberly-Clark Corp. https://foiadocs.com/products/fda-510k-k081048-pinnacle-pelvic-floor-repair-kit-ii 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K081048, PINNACLE PELVIC FLOOR REPAIR KIT II, by Boston Scientific Corp https://foiadocs.com/products/fda-510k-k081459-cusa-selector-nxt-ultrasonic-tissue-ablation-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K081459, CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM, by Integra Radionics, Inc. https://foiadocs.com/products/fda-510k-k081942-neurocath-ag 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K081942, NEUROCATH AG, by Vygon Neuro https://foiadocs.com/products/fda-510k-k072629-digimatch-robodoc-surgical-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K072629, DIGIMATCH ROBODOC SURGICAL SYSTEM, by Integrated Surgical Systems, Inc. https://foiadocs.com/products/fda-510k-k080668-g2-express-filter-system-femoral-rf400f-and-jugular-subclavian-rf400j-delivery-kits 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080668, G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS, by C.R. Bard, Inc. https://foiadocs.com/products/fda-510k-k072370-surgicraft-surgical-mesh-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K072370, SURGICRAFT SURGICAL MESH SYSTEM, by Surgicraft , Ltd. https://foiadocs.com/products/fda-510k-k063841-nmr-profiler-and-nmr-lipoprofile-assay-controls 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K063841, NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS, by Liposcience https://foiadocs.com/products/fda-510k-k081070-interlace-medical-operative-hysteroscopy-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K081070, INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM, by Interlace Medical, Inc. https://foiadocs.com/products/fda-510k-k080252-modification-to-mammaprint 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080252, MODIFICATION TO MAMMAPRINT, by Agendia BV https://foiadocs.com/products/fda-510k-k072741-pre-va-vaginal-lubricant 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K072741, PRE-VA VAGINAL LUBRICANT, by Ingfertility, LLC https://foiadocs.com/products/fda-510k-k080180-modification-to-retinal-function-imager-rfi 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080180, MODIFICATION TO RETINAL FUNCTION IMAGER (RFI), by Optical Imaging , Ltd. https://foiadocs.com/products/fda-510k-k080330-segmental-distal-femoral-components-and-proximal-femoral-bodies-with-a-compress-female-taper 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080330, SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER, by Biomet, Inc. https://foiadocs.com/products/fda-510k-k081379-modification-to-inreach-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K081379, MODIFICATION TO INREACH SYSTEM, by Superdimension, Ltd. https://foiadocs.com/products/fda-510k-k063723-impella-recover-lp-2-5-percutaneous-cardiac-support-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K063723, IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM, by Abiomed, Inc. https://foiadocs.com/products/fda-510k-k080631-cleanse-freshen-go-aligner-cleansing-towelette-and-dental-appliance-cleanser 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080631, CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER, by Oral Health Technologies, LLC https://foiadocs.com/products/fda-510k-k073311-osteotrans-ot-pin 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K073311, OSTEOTRANS-OT PIN, by Takiron Co., Ltd. https://foiadocs.com/products/fda-510k-k080093-pks-plasma-morcellator-models-962000pk-3620pk 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080093, PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK, by Gyrus Acmi, Inc. https://foiadocs.com/products/fda-510k-k080118-zeltiq-aesthetics-cln1-dermal-cooling-device 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080118, ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE, by Zeltiq Aesthetics https://foiadocs.com/products/fda-510k-k080383-aquacel-hydrofiber-wound-dressing-and-ag-hydrofiber-dressing 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080383, AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING, by Convatec, A Division of E.R. Squibb & Sons, LLC https://foiadocs.com/products/fda-510k-k073690-interlace-medical-hysteroscopic-morcellation-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K073690, INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM, by Interlace Medical, Inc. https://foiadocs.com/products/fda-510k-k080271-inreach-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080271, INREACH SYSTEM, by Superdimension, Ltd. https://foiadocs.com/products/fda-510k-k080295-charlotte-claw-3-5 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080295, CHARLOTTE CLAW 3.5, by Wrightmedicaltechnologyinc https://foiadocs.com/products/fda-510k-k072870-microwave-tissue-coagulation-system-mtcs 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K072870, MICROWAVE TISSUE COAGULATION SYSTEM (MTCS), by Foundry Newco X, Inc. https://foiadocs.com/products/fda-510k-k072684-mondeal-endoscopic-tissue-recession-and-release-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K072684, MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM, by Mondeal North America, Inc. https://foiadocs.com/products/fda-510k-k072776-the-crosser-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K072776, THE CROSSER SYSTEM, by Flowcardia, Inc. https://foiadocs.com/products/fda-510k-k071202-dermaport-percutaneous-vascular-access-system-pvas 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K071202, DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS), by Dermaport, Inc. https://foiadocs.com/products/fda-510k-k073102-biolox-delta-ceramic-heads-with-100kgy-e-poly-acetabular-liners 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K073102, BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS, by Biomet Manufacturing Corp https://foiadocs.com/products/fda-510k-k071371-copa-amd-antimicrobial-wound-dressing 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K071371, COPA AMD ANTIMICROBIAL WOUND DRESSING, by Tyco Healthcare Group LP https://foiadocs.com/products/fda-510k-k071535-biolox-delta-ceramic-femoral-head 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K071535, BIOLOX DELTA CERAMIC FEMORAL HEAD, by Zimmer, Inc. https://foiadocs.com/products/fda-510k-k072983-saturn-9000-750 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K072983, SATURN 9000-750, by New Medical Co., Ltd. https://foiadocs.com/products/fda-510k-k072343-neurovision-jjb-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K072343, NEUROVISION JJB SYSTEM, by Nuvasive, Inc. https://foiadocs.com/products/fda-510k-k072397-synoss-synthetic-bone-graft-material 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K072397, SYNOSS SYNTHETIC BONE GRAFT MATERIAL, by Collagen Matrix, Inc. https://foiadocs.com/products/fda-510k-k071920-autosuture-absorbable-tack-and-applicator 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K071920, AUTOSUTURE ABSORBABLE TACK AND APPLICATOR, by United States Surgical, A Division of Tyco Healthc https://foiadocs.com/products/fda-510k-k071530-karl-storz-video-flexible-video-ent-endoscope-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K071530, KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM, by KARL STORZ Endoscopy-America, Inc. https://foiadocs.com/products/fda-510k-k071354-mepilex-ag-dressing 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K071354, MEPILEX AG DRESSING, by Monlycke Health Care https://foiadocs.com/products/fda-510k-k071473-modification-to-superdimension-bronchus-premium-2 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K071473, MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2, by Superdimension, Ltd. https://foiadocs.com/products/fda-510k-k063876-modular-disinfection-system-mds-for-endoscope-reprocessing 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K063876, MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING, by Medivators Reprocessing Systems https://foiadocs.com/products/fda-510k-k071249-ultrapro-hernia-system-models-uhsl-uhsm-uhsov 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K071249, ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV, by ETHICON, Inc. https://foiadocs.com/products/fda-510k-k071092-asnis-micro-cannulated-screw 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K071092, ASNIS MICRO CANNULATED SCREW, by Howmedica Osteonics Corp. https://foiadocs.com/products/fda-510k-k063503-optivantage-dh-injector-system-with-enhanced-communication 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K063503, OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION, by Mallinckrodt Inc., Liebel-Flarsheim Business https://foiadocs.com/products/fda-510k-k070220-osteofix-bone-void-filler 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K070220, OSTEOFIX BONE VOID FILLER, by Calcitec, Inc. https://foiadocs.com/products/fda-510k-k070108-elibra-dynamic-knee-balancer 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K070108, ELIBRA DYNAMIC KNEE BALANCER, by Synvasive Technology, Inc. https://foiadocs.com/products/fda-510k-k070420-bioshield-ercp-biopsy-valve-model-00711138 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K070420, BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138, by United States Endoscopy Group, Inc. https://foiadocs.com/products/fda-510k-k063844-reprocessed-heart-stabilizers-and-positioners 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K063844, REPROCESSED HEART STABILIZERS AND POSITIONERS, by Sterilmed, Inc. https://foiadocs.com/products/fda-510k-k070173-verte-stack-spinal-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K070173, VERTE-STACK SPINAL SYSTEM, by Medtronic Sofamor Danek, Inc. https://foiadocs.com/products/fda-510k-k053342-gengigel-mouthrinse 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K053342, GENGIGEL MOUTHRINSE, by Ricerfarma Srl https://foiadocs.com/products/fda-510k-k063712-avaulta-support-system-avaulta-plus-biosynthetic-support-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K063712, AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM, by C.R. Bard, Inc. https://foiadocs.com/products/fda-510k-k062789-synthes-usa-rapid-resorbable-fixation-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062789, SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM, by Synthes (Usa) https://foiadocs.com/products/fda-510k-k063704-britewhite-teeth-whitening-system-model-bw1101 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K063704, BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101, by Beks Incorporated https://foiadocs.com/products/fda-510k-k063626-duraflex 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K063626, DURAFLEX, by Cosmetic Dental Materials, Inc. https://foiadocs.com/products/fda-510k-k063530-on-q-painbuster-c-bloc-select-a-flow-ondemand-homepump-eclipse-c-series-one-step-kvo-easypump 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K063530, ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP, by I-Flow Corp. https://foiadocs.com/products/fda-510k-k062849-smith-nephew-duonics-power-ii-shaver-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062849, SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM, by Smith & Nephew, Inc. https://foiadocs.com/products/fda-510k-k062998-compress-segmental-femoral-replacement-system-short-spindle-and-anchor-plug 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062998, COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG), by Biomet Manufacturing Corp https://foiadocs.com/products/fda-510k-k062176-relief-acp-oral-care-gel 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062176, RELIEF ACP ORAL CARE GEL, by Discus Dental, Inc. https://foiadocs.com/products/fda-510k-k062907-alexis-wound-retractor 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062907, ALEXIS WOUND RETRACTOR, by Applied Medical Resources https://foiadocs.com/products/fda-510k-k063166-i-t-s-pelvic-reconstruction-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K063166, I.T.S. PELVIC RECONSTRUCTION SYSTEM, by I.T.S. Implantat-Technologie-Systeme GmbH https://foiadocs.com/products/fda-510k-k062426-depuy-pinnacle-metal-on-metal-acetabular-cup-liners 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062426, DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS, by DePuy Orthopaedics, Inc. https://foiadocs.com/products/fda-510k-k061533-proceed-ventral-patch 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061533, PROCEED VENTRAL PATCH, by ETHICON, Inc. https://foiadocs.com/products/fda-510k-k063158-synthes-antegra-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K063158, SYNTHES ANTEGRA SYSTEM, by Synthes Spine Co.Lp https://foiadocs.com/products/fda-510k-k063204-spiderfx-embolic-protection-device 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K063204, SPIDERFX EMBOLIC PROTECTION DEVICE, by Ev3, Inc. https://foiadocs.com/products/fda-510k-k061718-innovacon-spectrum-ii-test-card 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061718, INNOVACON SPECTRUM II TEST CARD, by Innovacon, Inc. https://foiadocs.com/products/fda-510k-k053225-cellu-m6-keymodule-i 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K053225, CELLU M6 KEYMODULE I, by Lpg One, Inc. https://foiadocs.com/products/fda-510k-k062967-cyberknife-robotic-radiosurgery-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062967, CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM, by Accuray, Inc. https://foiadocs.com/products/fda-510k-k062251-reflexion-spiral-variable-radius-catheter-model-402804 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062251, REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804, by St Jude Medical https://foiadocs.com/products/fda-510k-k062481-sereno-electronic-stethoscope 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062481, SERENO ELECTRONIC STETHOSCOPE, by Pishon High Tech Co., Ltd. https://foiadocs.com/products/fda-510k-k062386-qangio-ct 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062386, QANGIO CT, by Medis Medical Imaging Systems BV https://foiadocs.com/products/fda-510k-k061996-sandman-pocket 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061996, SANDMAN POCKET, by Eb Neuro S.P.A. https://foiadocs.com/products/fda-510k-k061145-spermslow 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061145, SPERMSLOW, by Medicult A/S https://foiadocs.com/products/fda-510k-k062385-blue-ptfe-fluoroplastic-ventilation-tubes 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062385, BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES, by Grace Medical, Inc. https://foiadocs.com/products/fda-510k-k062408-smith-nephew-modular-femoral-hemi-head 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062408, SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD, by Smith & Nephew, Inc. https://foiadocs.com/products/fda-510k-k062315-superdimension-bronchus-premium-2 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062315, SUPERDIMENSION/BRONCHUS PREMIUM 2, by Superdimension, Ltd. https://foiadocs.com/products/fda-510k-k061248-axiem-imageless-hip-module-for-the-stealthstation-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061248, AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM, by Medtronic Navigation, Inc. https://foiadocs.com/products/fda-510k-k061555-anchor-laparscopic-tissue-retieval-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061555, ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM, by Anchor Products Co. https://foiadocs.com/products/fda-510k-k062259-iscience-surgical-fiberoptic-illuminator-model-fi-100 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062259, ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100, by Iscience Surgical https://foiadocs.com/products/fda-510k-k061226-trabecular-metal-acetabular-revision-system-cage 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061226, TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE, by Zimmer, Inc. https://foiadocs.com/products/fda-510k-k061247-diasorin-liaison-treponema-assay 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061247, DIASORIN LIAISON TREPONEMA ASSAY, by DiaSorin, Inc. https://foiadocs.com/products/fda-510k-k061556-amedica-drug-screen-thc-coc-opi-amp-met-pcp-mdma-bar-bzo-model-c1010-c1015-c1020 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061556, AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020, by Amedica Biotech, Inc. https://foiadocs.com/products/fda-510k-k061243-smith-nephew-modular-femoral-head 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061243, SMITH & NEPHEW MODULAR FEMORAL HEAD, by Smith & Nephew, Inc. https://foiadocs.com/products/fda-510k-k053656-tyrx-antimicrobial-mesh 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K053656, TYRX ANTIMICROBIAL MESH, by Tyrx Pharma, Inc. https://foiadocs.com/products/fda-510k-k061058-neozoline-ventilation-tubes 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061058, NEOZOLINE VENTILATION TUBES, by Adept Medical, Ltd. https://foiadocs.com/products/fda-510k-k052601-stockert-heater-cooler-system-3t 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K052601, STOCKERT HEATER-COOLER SYSTEM 3T, by Sorin Group Deutschland GmbH https://foiadocs.com/products/fda-510k-k061312-36mm-biolox-delta-ceramic-heads 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061312, 36MM BIOLOX DELTA CERAMIC HEADS, by Biomet, Inc. https://foiadocs.com/products/fda-510k-k061035-tigerview-professional 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061035, TIGERVIEW PROFESSIONAL, by Televere Systems https://foiadocs.com/products/fda-510k-k061095-auto-sutur-endo-gia-staplers 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061095, AUTO SUTUR ENDO GIA STAPLERS, by United States Surgical, A Division of Tyco Healthc https://foiadocs.com/products/fda-510k-k060865-bair-paws-temperature-management-system-model-850 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K060865, BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850, by Arizant Healthcare, Inc. https://foiadocs.com/products/fda-510k-k052457-picsi-sperm-selection-device 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K052457, PICSI SPERM SELECTION DEVICE, by Biocoat, Inc. https://foiadocs.com/products/fda-510k-k060515-depuy-pfc-sigma-knee-prosthesis 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K060515, DEPUY PFC SIGMA KNEE PROSTHESIS, by DePuy Orthopaedics, Inc. https://foiadocs.com/products/fda-510k-k051093-osteopore-pcl-scaffold 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K051093, OSTEOPORE PCL SCAFFOLD, by Osteopore, Inc. https://foiadocs.com/products/fda-510k-k053536-durom-acetabular-component-and-metasul-ldh-large-diameter-heads 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K053536, DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS, by Zimmer GmbH https://foiadocs.com/products/fda-510k-k060149-sunipan-imaging-system-accessories 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K060149, SUNIPAN IMAGING SYSTEM & ACCESSORIES, by Suni Medical Imaging, Inc. https://foiadocs.com/products/fda-510k-k052917-stryker-compartmental-knee-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K052917, STRYKER COMPARTMENTAL KNEE SYSTEM, by Howmedica Osteonics Corp. https://foiadocs.com/products/fda-510k-k052289-deepwave-neuromodulation-pain-therapy-device 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K052289, DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE, by Biowave Corporation https://foiadocs.com/products/fda-510k-k052396-oxysure-portable-oxygen-generator-model-615 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K052396, OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615, by Oxysure Systems, Inc. https://foiadocs.com/products/fda-510k-k053120-sterile-field-saline-and-heparin-lock-flush-syringes 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K053120, STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES, by Excelsior Medical Corp. https://foiadocs.com/products/fda-510k-k052257-vascular-solutions-twin-pass-dual-access-catheter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K052257, VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER, by Vascular Solutions, Inc. https://foiadocs.com/products/fda-510k-k052931-modification-to-verte-stack-spinal-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K052931, MODIFICATION TO VERTE-STACK SPINAL SYSTEM, by Medtronic Sofamor Danek https://foiadocs.com/products/fda-510k-k052852-superdimension-bronchus-premium 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K052852, SUPERDIMENSION/BRONCHUS PREMIUM, by Superdimension, Ltd. https://foiadocs.com/products/fda-510k-k052718-v40-biolox-delta-ceramic-femoral-heads 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K052718, V40 BIOLOX DELTA CERAMIC FEMORAL HEADS, by Howmedica Osteonics Corp. https://foiadocs.com/products/fda-510k-k052309-digital-hand-dynamometer-model-sh5003-digital-pinch-gauge-model-sh5006 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K052309, DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006, by Saehan Corp. https://foiadocs.com/products/fda-510k-k052260-superdimension-bronchus-4-1 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K052260, SUPERDIMENSION/BRONCHUS 4.1, by Superdimension, Ltd. https://foiadocs.com/products/fda-510k-k051980-dvt-scanner 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K051980, DVT SCANNER, by Imaging Sciences Intl., Inc. https://foiadocs.com/products/fda-510k-k043465-2-5-mm-turbo-clirpath-excimer-laser-catheter-model-225-011 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K043465, 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011, by Spectranetics Corp. https://foiadocs.com/products/fda-510k-k052051-omni-sphincterotome 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K052051, OMNI SPHINCTEROTOME, by Wilson-Cook Medical, Inc. https://foiadocs.com/products/fda-510k-k051664-scan300fp-retropan-vdc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K051664, SCAN300FP / RETROPAN (VDC), by Oy Ajat, Ltd. https://foiadocs.com/products/fda-510k-k051588-biolox-delta-ceramic-femoral-heads 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K051588, BIOLOX DELTA CERAMIC FEMORAL HEADS, by Howmedica Osteonics Corp. https://foiadocs.com/products/fda-510k-k051411-arcomxl-polyethylene-liners-and-biolox-delta-heads 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K051411, ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS, by Biomet, Inc. https://foiadocs.com/products/fda-510k-k050036-fes-cycle-ergometer-model-rt300-s 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K050036, FES CYCLE ERGOMETER, MODEL RT300-S, by Restorative Therapies, Inc. https://foiadocs.com/products/fda-510k-k050273-fresenius-art-hemoadsorption-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K050273, FRESENIUS ART HEMOADSORPTION SYSTEM, by Fresenius Medical Care North America https://foiadocs.com/products/fda-510k-k042912-interx5000 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042912, INTERX5000, by Neuro Resource Group, Inc. https://foiadocs.com/products/fda-510k-k051002-endopath-endocutter-60-endoscopic-linear-cutter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K051002, ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, by Ethicon Endo-Surgery, Inc. https://foiadocs.com/products/fda-510k-k050937-trabecular-metal-acetabular-revision-shells 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K050937, TRABECULAR METAL ACETABULAR REVISION SHELLS, by Zimmer Trabecular https://foiadocs.com/products/fda-510k-k043555-synthes-9usa-alveolar-ridge-distractor 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K043555, SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR, by Synthes (Usa) https://foiadocs.com/products/fda-510k-k050225-heartwave-ii-cardiac-diagnostic-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K050225, HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM, by Cambridge Heart, Inc. https://foiadocs.com/products/fda-510k-k042091-biolox-delta-ceramic-heads 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042091, BIOLOX DELTA CERAMIC HEADS, by Biomet, Inc. https://foiadocs.com/products/fda-510k-k050344-ligaclip-5-m-l-mm-endoscopic-multiple-clip-applier 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K050344, LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER, by Ethicon Endo Surgery, Inc. https://foiadocs.com/products/fda-510k-k050275-modification-to-inion-otps-biodegradable-pin 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K050275, MODIFICATION TO: INION OTPS BIODEGRADABLE PIN, by Inion , Ltd. https://foiadocs.com/products/fda-510k-k050338-modification-to-instaread-lithium-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K050338, MODIFICATION TO: INSTAREAD LITHIUM SYSTEM, by Akers Biosciences, Inc. https://foiadocs.com/products/fda-510k-k050159-modification-to-3m-littmann-electronic-stethoscope-model-3000 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K050159, MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000, by 3M Company https://foiadocs.com/products/fda-510k-k043557-model-pc-1000-panoramic-cephalometric-x-ray-systems 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K043557, MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS, by Panoramic Corp. https://foiadocs.com/products/fda-510k-k042657-vioptix-odissey-tissue-oximeter-tissue-oximeter-model-oxy-2 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042657, VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2, by Vioptix, Inc. https://foiadocs.com/products/fda-510k-k042938-gambro-prismaflex-hf1000-and-hf1400-sets 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042938, GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS, by Gambro Renal Products https://foiadocs.com/products/fda-510k-k042911-cementek-lv 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042911, CEMENTEK LV, by Teknimed, S.A. https://foiadocs.com/products/fda-510k-k042841-m2a-c2a-acetabular-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042841, M2A/C2A ACETABULAR SYSTEM, by Biomet, Inc. https://foiadocs.com/products/fda-510k-k041623-reusable-sterilcontainer-filter-model-jk090 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K041623, REUSABLE STERILCONTAINER FILTER MODEL #JK090, by Aesculap, Inc. https://foiadocs.com/products/fda-510k-k042784-medrad-spectris-solaris-ep-mr-injector-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042784, MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM, by Medrad, Inc. https://foiadocs.com/products/fda-510k-k042076-fujinon-g5-duodenscopes-g5-duodenoscopes-ed-450xt5-ed-250xt5 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042076, FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5, by Fujinon, Inc. https://foiadocs.com/products/fda-510k-k042889-dynamometer-model-fce-and-model-msc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042889, DYNAMOMETER - MODEL FCE AND MODEL MSC, by Ametek https://foiadocs.com/products/fda-510k-k042231-gelspheres-microspheres-and-bead-block-compressible-microspheres 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042231, GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES, by Biocompatibles UK Limited https://foiadocs.com/products/fda-510k-k040021-shuntcheck-prometheus-1 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K040021, SHUNTCHECK (PROMETHEUS 1), by Samuel Neff M.D. https://foiadocs.com/products/fda-510k-k042750-qc-beads 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042750, QC-BEADS, by Bioscreen, Inc. https://foiadocs.com/products/fda-510k-k040839-complete-blink-n-clean-lens-drops 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K040839, COMPLETE BLINK-N-CLEAN LENS DROPS, by Advanced Medical Optics, Inc. https://foiadocs.com/products/fda-510k-k041934-3m-littmann-electronic-stethoscope-model-3000 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K041934, 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000, by 3M Company https://foiadocs.com/products/fda-510k-k042501-etg-4000-optical-topography-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042501, ETG-4000 OPTICAL TOPOGRAPHY SYSTEM, by Hitachi Medical Corp. https://foiadocs.com/products/fda-510k-k042616-biomedix-padnet-lab 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042616, BIOMEDIX PADNET LAB, by Biomedix, Inc. https://foiadocs.com/products/fda-510k-k041528-modification-to-eptfe-graft 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K041528, MODIFICATION TO EPTFE GRAFT, by Vascutek, Ltd. https://foiadocs.com/products/fda-510k-k041493-cementek 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K041493, CEMENTEK, by Teknimed, S.A. https://foiadocs.com/products/fda-510k-k041889-tri-ostetic 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K041889, TRI-OSTETIC, by Berkeley Advanced Biomaterials, Inc. https://foiadocs.com/products/fda-510k-k040490-welch-allyn-spot-ultra-vital-signs-device 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K040490, WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE, by Welch Allyn, Inc. https://foiadocs.com/products/fda-510k-k041263-neuroguide-analysis-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K041263, NEUROGUIDE ANALYSIS SYSTEM, by Applied Neuroscience, Inc. https://foiadocs.com/products/fda-510k-k041338-medtronic-octopus-te-stabilizer-accessories 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K041338, MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES, by Medtronic Vascular https://foiadocs.com/products/fda-510k-k040554-actigraph-model-am7164-2-2-and-actigraph-with-extended-memory-model-am71256 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K040554, ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256, by Manufacturing Technology, Inc. https://foiadocs.com/products/fda-510k-k041148-pocone-infrared-spectrophotometer 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K041148, POCONE INFRARED SPECTROPHOTOMETER, by Otsuka Pharmaceutical Co., Ltd. https://foiadocs.com/products/fda-510k-k033448-electro-optical-air-sterilizer-with-ionizer 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K033448, ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER, by John Mfg., Ltd. https://foiadocs.com/products/fda-510k-k040416-sonicare-advance-toothbrush-model-4900 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K040416, SONICARE ADVANCE TOOTHBRUSH, MODEL 4900, by Philips Oral Healthcare, Inc. https://foiadocs.com/products/fda-510k-k040911-vitalheat 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K040911, VITALHEAT, by Dynatherm Medical, Inc. https://foiadocs.com/products/fda-510k-k040512-limited-function-wl-otc-tens-device-model-wl-2103a-wl-2203a-wl-2203b-and-wl-2401 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K040512, LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401, by Well-Life Healthcare, Inc. https://foiadocs.com/products/fda-510k-k040389-coonrad-morrey-elbow-cement-restrictor 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K040389, COONRAD/MORREY ELBOW CEMENT RESTRICTOR, by Zimmer, Inc. https://foiadocs.com/products/fda-510k-k040981-usw-needleknife-papillotome 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K040981, USW NEEDLEKNIFE PAPILLOTOME, by Wilson-Cook Medical, Inc. https://foiadocs.com/products/fda-510k-k040067-clirpath-excimer-laser-catheter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K040067, CLIRPATH EXCIMER LASER CATHETER, by Spectranetics Corp. https://foiadocs.com/products/fda-510k-k033485-endoscout 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K033485, ENDOSCOUT, by Robin Medical, Inc. https://foiadocs.com/products/fda-510k-k033998-masimo-set-rad-5v-pulse-oximeter-model-rad-5v 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K033998, MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V, by Masimo Corp. https://foiadocs.com/products/fda-510k-k040073-sysmex-automated-hematology-analyzer-xe-2100-series-xe-2100-xe-2100l 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K040073, SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L), by Sysmex America, Inc. https://foiadocs.com/products/fda-510k-k033967-telethermographic-camera-series-a-e-s-and-p 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K033967, TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P, by Flir Systems https://foiadocs.com/products/fda-510k-k040405-cem-ostetic-putty-injection-kit-model-pik-xx-pik-xx-yy 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K040405, CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY, by Berkeley Advanced Biomaterials, Inc. https://foiadocs.com/products/fda-510k-k033981-smith-nephew-electrothermal-20s-spine-generator-model-7209975 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K033981, SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975, by Smith & Nephew, Inc. https://foiadocs.com/products/fda-510k-k040183-bisx 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K040183, BISX, by Aspect Medical Systems, Inc. https://foiadocs.com/products/fda-510k-k033820-microlife-digital-infrared-forehead-thermometer-model-fr1dm1 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K033820, MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1, by Microlife Intellectual Property GmbH https://foiadocs.com/products/fda-510k-k032350-infrared-sciences-breastscan-ir-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K032350, INFRARED SCIENCES BREASTSCAN IR SYSTEM, by Infrared Sciences Corp. https://foiadocs.com/products/fda-510k-k033769-eius-unicompartmental-knee-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K033769, EIUS UNICOMPARTMENTAL KNEE SYSTEM, by Howmedica Osteonics Corp. https://foiadocs.com/products/fda-510k-k033671-gore-bioabsorbable-mesh 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K033671, GORE BIOABSORBABLE MESH, by W. L. Gore & Associates, Inc. https://foiadocs.com/products/fda-510k-k032571-immulisa-anti-human-tissue-transglutaminase-hu-ttg-antibody-iga-elisa 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K032571, IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA, by Immco Diagnostics, Inc. https://foiadocs.com/products/fda-510k-k033269-endopath-endocutter-gray-cartridge-model-6r45m-gray-cartridge-reload 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K033269, ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD, by Ethicon Endo-Surgery, Inc. https://foiadocs.com/products/fda-510k-k033568-gynecare-tvt-obturator-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K033568, GYNECARE TVT OBTURATOR SYSTEM, by ETHICON, Inc. https://foiadocs.com/products/fda-510k-k033021-kimberly-clark-patient-warming-system-model-100-control-unit-and-energy-transfer-pads 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K033021, KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS, by Kimberly-Clark Corp. https://foiadocs.com/products/fda-510k-k033275-lifepak-12-20-500-cr-plus 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K033275, LIFEPAK 12, 20, 500, CR PLUS, by Medtronic Physio-Control Corp. https://foiadocs.com/products/fda-510k-k032481-theratears-contact-lens-comfort-drops 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K032481, THERATEARS CONTACT LENS COMFORT DROPS, by Advanced Vision Research, Inc. https://foiadocs.com/products/fda-510k-k031838-profusion-bone-void-filler-kit 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K031838, PROFUSION BONE VOID FILLER KIT, by Biogeneration https://foiadocs.com/products/fda-510k-k024322-embla-n7000 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K024322, EMBLA N7000, by Medcare Flaga https://foiadocs.com/products/fda-510k-k032482-stanbio-laboratory-hemopoint-h2-hemoglobin-measurement-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K032482, STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM, by Stanbio Laboratory https://foiadocs.com/products/fda-510k-k032115-neurolac-nerve-guide-models-ng01-15-03-ng01-020-03-ng01-025-03-ng01-030-03 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K032115, NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03, by Polyganics B.V., https://foiadocs.com/products/fda-510k-k030886-nico-with-mars-model-7300 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K030886, NICO WITH MARS, MODEL 7300, by Respironics Novametrix, Inc. https://foiadocs.com/products/fda-510k-k032030-blink-cl-lubricant-eye-drops 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K032030, BLINK CL LUBRICANT EYE DROPS, by Advanced Medical Optics, Inc. https://foiadocs.com/products/fda-510k-k030719-pentacam-scheimpflug-camera 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K030719, PENTACAM SCHEIMPFLUG CAMERA, by Oculus Optikgerate GmbH https://foiadocs.com/products/fda-510k-k031359-s-monovette-edta-k2-gel 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K031359, S-MONOVETTE EDTA K2-GEL, by Sarstedt, Inc. https://foiadocs.com/products/fda-510k-k032163-duracon-total-knee-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K032163, DURACON TOTAL KNEE SYSTEM, by Howmedica Osteonics Corp. https://foiadocs.com/products/fda-510k-k032203-hemocue-hemoglobin-201-system-article-121704 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K032203, HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704, by Hemocue, Inc. https://foiadocs.com/products/fda-510k-k031544-heater-cooler-unit-model-hcu-30 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K031544, HEATER COOLER UNIT, MODEL HCU 30, by Jostra AB https://foiadocs.com/products/fda-510k-k031435-bonesource-bvf 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K031435, BONESOURCE BVF, by Howmedica Osteonics https://foiadocs.com/products/fda-510k-k024367-sinclair-wound-and-skin-emulsion 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K024367, SINCLAIR WOUND AND SKIN EMULSION, by Sinclair Pharmaceuticals, Ltd. https://foiadocs.com/products/fda-510k-k030605-rapid-imf 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K030605, RAPID IMF, by Zygomatics , Ltd. https://foiadocs.com/products/fda-510k-k031011-ligasure-5mm-laparoscopic-sealer-divider-model-ls1500 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K031011, LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500, by Valleylab, Inc. https://foiadocs.com/products/fda-510k-k030974-exeltra-high-flux-dialyzer-models-150-170 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K030974, EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170, by Baxter Healthcare Corp https://foiadocs.com/products/fda-510k-k023872-vitalcare-urethral-catheter-red-rubber 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K023872, VITALCARE URETHRAL CATHETER RED RUBBER, by Vitalcare, Inc. https://foiadocs.com/products/fda-510k-k030940-nomad-nd1000m-augmented-vision-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K030940, NOMAD ND1000M AUGMENTED VISION SYSTEM, by Microvision Incorporated https://foiadocs.com/products/fda-510k-k030982-syngo-colonography-software-package 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K030982, SYNGO COLONOGRAPHY SOFTWARE PACKAGE, by Siemens Medical Solutions USA, Inc. https://foiadocs.com/products/fda-510k-k030009-ksea-powershaver-system-s2 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K030009, KSEA POWERSHAVER SYSTEM S2, by Karl Storz Endoscopy https://foiadocs.com/products/fda-510k-k030688-echelon-micro-catheter-model-105-5092-150 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K030688, ECHELON MICRO CATHETER, MODEL 105-5092-150, by Micro Therapeutics, Inc. https://foiadocs.com/products/fda-510k-k030611-modification-to-suzanne-portable-polysomnograph-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K030611, MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM, by Nellcor Puritan Bennett (Melville) , Ltd. https://foiadocs.com/products/fda-510k-k030289-hermetic-plus-external-csf-drainage-systems-ins-8301-ins-8302-ins-8700-nl850-830n 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K030289, HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N, by Integra Lifesciences Corp. https://foiadocs.com/products/fda-510k-k030311-hem-o-lok-xl-clip 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K030311, HEM-O-LOK XL CLIP, by Weck https://foiadocs.com/products/fda-510k-k023238-mcpulse 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K023238, MCPULSE, by Meridian Co., Ltd. https://foiadocs.com/products/fda-510k-k024071-guidant-syncrus-internal-cardioversion-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K024071, GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM, by Guidant Corporation, Cardiac Surgery https://foiadocs.com/products/fda-510k-k023830-airocide-ti02 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K023830, AIROCIDE TI02, by Kes Science & Technology, Inc. https://foiadocs.com/products/fda-510k-k023254-speedicath 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K023254, SPEEDICATH, by Coloplast Corp. https://foiadocs.com/products/fda-510k-k023183-medrad-stellant-ct-injector-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K023183, MEDRAD STELLANT CT INJECTOR SYSTEM, by Medrad, Inc. https://foiadocs.com/products/fda-510k-k022622-cem-ostetic-models-cemo-020o-cemo-05p-cemo-10p-cemo-20p-and-cemo-30p 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K022622, CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P, by Berkeley Advanced Biomaterials, Inc. https://foiadocs.com/products/fda-510k-k023883-homepump-eclipse-c-series-painbuster-c-bloc-on-q-easypump-kvo 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K023883, HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO, by I-Flow Corp. https://foiadocs.com/products/fda-510k-k024060-modification-to-asnis-iii-cannulated-screw-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K024060, MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM, by Howmedica Osteonics Corp. https://foiadocs.com/products/fda-510k-k023087-global-modular-replacement-system-gmrs 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K023087, GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS), by Howmedica Osteonics Corp. https://foiadocs.com/products/fda-510k-k023928-mas-ua-control-liquid-assayed-urinalysis-control-dade-assayed-urinalysis-control 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K023928, MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL, by Medical Analysis Systems, Inc. https://foiadocs.com/products/fda-510k-k023075-bd-vacutainer-plus-sst-serum-separator-tube 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K023075, BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE, by Bd Vacutainer Systems Preanalyical Solutions https://foiadocs.com/products/fda-510k-k020715-philips-m5066a-and-m5068a 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K020715, PHILIPS M5066A AND M5068A, by Philips Medical Systems https://foiadocs.com/products/fda-510k-k023318-i-flow-elastomeric-pump-with-bolus 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K023318, I-FLOW ELASTOMERIC PUMP WITH BOLUS, by I-Flow Corp. https://foiadocs.com/products/fda-510k-k022869-soaker-catheter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K022869, SOAKER CATHETER, by I-Flow Corp. https://foiadocs.com/products/fda-510k-k022006-conductive-gel 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K022006, CONDUCTIVE GEL, by The Dezac Group https://foiadocs.com/products/fda-510k-k022782-dualmesh-emerge-emerge-plus-biomaterial 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K022782, DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL, by W. L. Gore & Associates, Inc. https://foiadocs.com/products/fda-510k-k021792-bilayer-matrix-wound-dressing 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K021792, BILAYER MATRIX WOUND DRESSING, by Integra Lifesciences Corp. https://foiadocs.com/products/fda-510k-k021808-weck-hem-o-lok-automatic-ligating-clip-applier 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K021808, WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER, by Weck https://foiadocs.com/products/fda-510k-k010727-flexline-clamp 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K010727, FLEXLINE CLAMP, by Novare Surgical Systems, Inc. https://foiadocs.com/products/fda-510k-k011741-crit-line-monitor-iii-tqa-clm-tqa 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K011741, CRIT-LINE MONITOR III TQA (CLM TQA), by Hemametrics https://foiadocs.com/products/fda-510k-k022149-cardiac-diagnostic-system-model-ch2000 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K022149, CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000, by Cambridge Heart, Inc. https://foiadocs.com/products/fda-510k-k021094-introcan-safety-iv-catheter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K021094, INTROCAN SAFETY IV CATHETER, by B.Braun Medical, Inc. https://foiadocs.com/products/fda-510k-k020399-resperate-model-rr-150 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K020399, RESPERATE; MODEL RR-150, by Intercure , Ltd. https://foiadocs.com/products/fda-510k-k003720-angel-of-water-colon-hydrotherapy-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K003720, ANGEL OF WATER COLON HYDROTHERAPY SYSTEM, by Lifestream Purfication Systems, LLC https://foiadocs.com/products/fda-510k-k020732-ss-matrix 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K020732, SS MATRIX, by Cook Biotech, Inc. https://foiadocs.com/products/fda-510k-k021344-b-f200-bronchoscope-with-bss-f21-endosheath-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K021344, B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM, by Vision-Sciences, Inc. https://foiadocs.com/products/fda-510k-k020988-pain-care-4200 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K020988, PAIN CARE 4200, by Breg, Inc. https://foiadocs.com/products/fda-510k-k020659-durex-latex-condom-with-male-genital-desensitizer-lubricant 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K020659, DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT, by Ssl Americas, Inc. https://foiadocs.com/products/fda-510k-k020660-homepump-eclipse-c-series-painbuster-c-bloc-on-q-easypump-one-step-kvo 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K020660, HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO, by I-Flow Corp. https://foiadocs.com/products/fda-510k-k020251-paragon-infusion-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K020251, PARAGON INFUSION SYSTEM, by I-Flow Corp. https://foiadocs.com/products/fda-510k-k012439-dentaleye-2-dental-image-management-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K012439, DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM, by Radco Data AB https://foiadocs.com/products/fda-510k-k013971-bd-vacutainer-safety-coagulation-tube 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K013971, BD VACUTAINER SAFETY COAGULATION TUBE, by Becton, Dickinson & CO https://foiadocs.com/products/fda-510k-k013289-bioteque-vaginal-pessaries 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K013289, BIOTEQUE VAGINAL PESSARIES, by Bioteque America, Inc. https://foiadocs.com/products/fda-510k-k011702-vertis-pnt-control-unit-vertis-pnt-safeguide-kids-models-cu100-sgxxx 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K011702, VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX, by Vertis Neuroscience, Inc. https://foiadocs.com/products/fda-510k-k013928-pain-care-3200 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K013928, PAIN CARE 3200, by Breg, Inc. https://foiadocs.com/products/fda-510k-k011812-spectrum-ventricular-catheter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K011812, SPECTRUM VENTRICULAR CATHETER, by Cook, Inc. https://foiadocs.com/products/fda-510k-k010335-slendertone-flex-model-512 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K010335, SLENDERTONE FLEX, MODEL, 512, by Bio-Medical Research, Ltd. https://foiadocs.com/products/fda-510k-k011571-trxf-intelligent-dosing-system-ids-dosing-calculator-suite 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K011571, TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE, by The RX Files Corp. https://foiadocs.com/products/fda-510k-k011251-sparc-sling-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K011251, SPARC SLING SYSTEM, by American Medical Systems, Inc. https://foiadocs.com/products/fda-510k-k011291-temporalscanner-thermometer-sensortouch 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K011291, TEMPORALSCANNER THERMOMETER, SENSORTOUCH, by Exergen Corp. https://foiadocs.com/products/fda-510k-k011566-quanta-lite-h-ttg-human-tissue-transglutaminase-iga-elisa 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K011566, QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA, by Inova Diagnostics, Inc. https://foiadocs.com/products/fda-510k-k011071-paradigm-quick-set-infusion-set 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K011071, PARADIGM QUICK-SET INFUSION SET, by Maersk Medical A/S https://foiadocs.com/products/fda-510k-k011364-custom-tci-tinnitus-control-instrument 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K011364, CUSTOM TCI (TINNITUS CONTROL INSTRUMENT), by Siemens Hearing Instruments, Inc. https://foiadocs.com/products/fda-510k-k011366-custom-tci-combi-tinnitus-control-instrument-combination 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K011366, CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION), by Siemens Hearing Instruments, Inc. https://foiadocs.com/products/fda-510k-k011369-ultrasafe-passive-x-series-needle-guard-syringe-piston-accessory 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K011369, ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY), by Safety Syringes, Inc. https://foiadocs.com/products/fda-510k-k011149-disposable-bending-cannula-pr-233q 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K011149, DISPOSABLE BENDING CANNULA PR-233Q, by The Olympus Optical Co. https://foiadocs.com/products/fda-510k-k010460-lifelines-trackit 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K010460, LIFELINES TRACKIT, by Lifelines , Ltd. https://foiadocs.com/products/fda-510k-k010993-alien-rx-micro-cannula-model-4530 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K010993, ALIEN RX MICRO CANNULA, MODEL 4530, by Boston Scientific Corp https://foiadocs.com/products/fda-510k-k003559-tci-tinnitus-control-instrument 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K003559, TCI (TINNITUS CONTROL INSTRUMENT), by Siemens Hearing Instruments, Inc. https://foiadocs.com/products/fda-510k-k003987-urs-1k-ketone-tesst 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K003987, URS-1K (KETONE TESST), by Teco Diagnostics https://foiadocs.com/products/fda-510k-k000881-perfadex-solution-for-organ-preservation 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K000881, PERFADEX SOLUTION FOR ORGAN PRESERVATION, by Vitrolife Sweden AB https://foiadocs.com/products/fda-510k-k002095-snap-model-6 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K002095, SNAP MODEL 6, by Snap Laboratories, LLC https://foiadocs.com/products/fda-510k-k003487-stimate-n601-tens 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K003487, STIMATE N601 TENS, by Everyway Medical Instruments Co.,Ltd https://foiadocs.com/products/fda-510k-k002488-kelo-cote-topical-gel 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K002488, KELO-COTE TOPICAL GEL, by Advanced Bio-Technologies, Inc. https://foiadocs.com/products/fda-510k-k003154-mizar-basis-be-sandman-digital 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K003154, MIZAR, BASIS BE, SANDMAN DIGITAL, by Eb Neuro S.P.A. https://foiadocs.com/products/fda-510k-k003269-unicondylar-interpositional-spacer 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K003269, UNICONDYLAR INTERPOSITIONAL SPACER, by Sulzer Orthopedics, Inc. https://foiadocs.com/products/fda-510k-k003305-pediatric-ingestascan 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K003305, PEDIATRIC INGESTASCAN, by Adams Electronics, Inc. https://foiadocs.com/products/fda-510k-k003337-hem-o-lok-smx-model-544220-hem-o-lok-ml-model-544230-hem-o-lok-mlx-model-544240 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K003337, HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240, by Weck Closure Systems https://foiadocs.com/products/fda-510k-k002996-synergy-ha-coated-porous-femoral-stems 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K002996, SYNERGY HA COATED POROUS FEMORAL STEMS, by Smith & Nephew, Inc. https://foiadocs.com/products/fda-510k-k003028-cytoplast-suture-cs-0318-cs-0416-cs-0418-cs-0513-cs-0513pc-cs-0516hc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K003028, CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC, by Osteogenics Biomedical, Inc. https://foiadocs.com/products/fda-510k-k001520-alpha-omega-dual-cooler-heater 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K001520, ALPHA OMEGA DUAL COOLER-HEATER, by Alpha Omega, Inc. https://foiadocs.com/products/fda-510k-k002913-headband-for-baha 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K002913, HEADBAND FOR BAHA, by Entific Medical Systems, Inc. https://foiadocs.com/products/fda-510k-k002883-pinnacle-metal-on-metal-acetabular-cup-liners 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K002883, PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS, by DePuy Orthopaedics, Inc. https://foiadocs.com/products/fda-510k-k002255-laryngo-tracheal-mucosal-atomization-device-madgic 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K002255, LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC), by Wolfe Tory Medical, Inc. https://foiadocs.com/products/fda-510k-k002138-paradigm-silhouette-models-mmt-377-378-379-380 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K002138, PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380, by Maersk Medical A/S https://foiadocs.com/products/fda-510k-k001960-rigid-gas-permeable-contact-lens 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K001960, RIGID GAS PERMEABLE CONTACT LENS, by Polymer Technology https://foiadocs.com/products/fda-510k-k002321-pain-care-2000l 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K002321, PAIN CARE 2000L, by Breg, Inc. https://foiadocs.com/products/fda-510k-k001989-coonrad-morrey-total-elbow-model-32-8105-series 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K001989, COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES, by Zimmer, Inc. https://foiadocs.com/products/fda-510k-k001217-inside-view 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K001217, INSIDE VIEW, by Monadnock Optics, Inc. https://foiadocs.com/products/fda-510k-k000669-medivision-i-view-personal-video-display 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K000669, MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY, by Medivision Endoscopy https://foiadocs.com/products/fda-510k-k000795-rigid-gas-permeable-contact-lens 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K000795, RIGID GAS PERMEABLE CONTACT LENS, by Polymer Technology https://foiadocs.com/products/fda-510k-k000609-cardtel-model-nt-100 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K000609, CARDTEL, MODEL NT-100, by Cardiac Telecommunications https://foiadocs.com/products/fda-510k-k001122-prolene-soft-polypropylene-nonabsorbabale-synthetic-surgical-mesh 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K001122, PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH, by ETHICON, Inc. https://foiadocs.com/products/fda-510k-k001086-free-testosterone-enzyme-immunoassay-model-dsl-10-4900 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K001086, FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900, by Diagnostic Systems Laboratories, Inc. https://foiadocs.com/products/fda-510k-k000281-wallstent-enternal-prosthesis 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K000281, WALLSTENT ENTERNAL PROSTHESIS, by Boston Scientific Corp https://foiadocs.com/products/fda-510k-k000080-asnis-iii-cannulated-screw-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K000080, ASNIS III CANNULATED SCREW SYSTEM, by Howmedica Osteonics Corp. https://foiadocs.com/products/fda-510k-k000365-accu-chek-advantage-meter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K000365, ACCU-CHEK ADVANTAGE METER, by Roche Diagnostics Corp. https://foiadocs.com/products/fda-510k-k993900-coagulation-electrode-model-2000-radiofrequency-generator-model-20-115 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K993900, COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115, by Broncus Technologies, Inc. https://foiadocs.com/products/fda-510k-k992209-custodiol 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K992209, CUSTODIOL, by Dr. Franz Kohler Chemie GmbH https://foiadocs.com/products/fda-510k-k992341-cidex-opa-solution-test-strip 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K992341, CIDEX OPA SOLUTION TEST STRIP, by Serim Research Corp. https://foiadocs.com/products/fda-510k-k992832-sulzer-vascutek-eptfe-vascular-prosthesis 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K992832, SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS, by Sulzermedica https://foiadocs.com/products/fda-510k-k991786-mars-unity-workstation-with-heart-rate-variability-hrv-option 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K991786, MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION, by General Electric Medical Systems Information Techn https://foiadocs.com/products/fda-510k-k992833-vacuum-assist-stabilizer 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K992833, VACUUM ASSIST STABILIZER, by Cardio Thoracic Systems https://foiadocs.com/products/fda-510k-k992969-respironics-total-face-mask 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K992969, RESPIRONICS TOTAL FACE MASK, by Respironics, Inc. https://foiadocs.com/products/fda-510k-k991543-intraop-catheter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K991543, INTRAOP CATHETER, by I-Flow Corp. https://foiadocs.com/products/fda-510k-k990276-porous-media-dpb30-series-disposable-pre-bypass-filter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K990276, POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER, by Porous Media Corp. https://foiadocs.com/products/fda-510k-k992693-rita-model-90-electrosurgical-accessory-model-90 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K992693, RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90, by Rita Medical Systems https://foiadocs.com/products/fda-510k-k992379-radionics-xdc-external-ventricular-catheter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K992379, RADIONICS XDC EXTERNAL VENTRICULAR CATHETER, by Radionics, Inc. https://foiadocs.com/products/fda-510k-k990470-jms-a-v-fistula-needle-set 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K990470, JMS A. V. FISTULA NEEDLE SET, by Jms Co., Ltd. https://foiadocs.com/products/fda-510k-k991642-eye-trak-tm-computerized-electronystagmograph-eng-model-etv-xxxx 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K991642, EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX, by Bertec Corp. https://foiadocs.com/products/fda-510k-k990560-life-imaging-systems-model-l3di 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K990560, LIFE IMAGING SYSTEMS, MODEL L3DI, by Life Imaging Systems, Inc. https://foiadocs.com/products/fda-510k-k990328-dbc-dong-bang-acupuncture-needles 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K990328, DBC, DONG BANG ACUPUNCTURE NEEDLES, by Morning Star, Dong Bang Acupuncture U.S.A., Inc. https://foiadocs.com/products/fda-510k-k983483-vascular-occlusion-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K983483, VASCULAR OCCLUSION SYSTEM, by Cordis Neurovascular, Inc. https://foiadocs.com/products/fda-510k-k990184-automarqer 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K990184, AUTOMARQER, by Hamilton Thorne Research https://foiadocs.com/products/fda-510k-k984443-orbscan 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K984443, ORBSCAN, by Technolas Perfect Vision GmbH https://foiadocs.com/products/fda-510k-k984146-paragon-infusion 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K984146, PARAGON INFUSION, by I-Flow Corp. https://foiadocs.com/products/fda-510k-k984638-paragon-bolus-accessory-set 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K984638, PARAGON BOLUS ACCESSORY SET, by I-Flow Corp. https://foiadocs.com/products/fda-510k-k984053-becker-external-drainage-and-monitoring-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K984053, BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM, by Medtronic PS Medical https://foiadocs.com/products/fda-510k-k982385-porous-media-dpb20-series-disposable-pre-bypass-filter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K982385, POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER, by Porous Media Corp. https://foiadocs.com/products/fda-510k-k984167-sage-7 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K984167, SAGE 7, by GE Medical Systems https://foiadocs.com/products/fda-510k-k983454-pain-care-2000 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K983454, PAIN CARE 2000, by Breg, Inc. https://foiadocs.com/products/fda-510k-k983210-algisite-m 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K983210, ALGISITE M, by Smith & Nephew, Inc. https://foiadocs.com/products/fda-510k-k983517-safe-t-fill-capillary-blood-collection-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K983517, SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM, by Ram Scientific https://foiadocs.com/products/fda-510k-k982412-modification-of-crit-line-monitor-iii-clm-iii 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K982412, MODIFICATION OF CRIT-LINE MONITOR III (CLM III), by In-Line Diagnostics Corp. https://foiadocs.com/products/fda-510k-k981916-ligasure-vessel-sealing-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K981916, LIGASURE VESSEL SEALING SYSTEM, by Valleylab, Inc. https://foiadocs.com/products/fda-510k-k974479-silimed-vaginal-stent 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K974479, SILIMED VAGINAL STENT, by Silimed, LLC https://foiadocs.com/products/fda-510k-k981730-digit-grip-with-lcd-model-number-dgr-002 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K981730, DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002, by Nk Biotechnical Corp. https://foiadocs.com/products/fda-510k-k980814-puresperm 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K980814, PURESPERM, by Nidacon International AB https://foiadocs.com/products/fda-510k-k981013-vacutainer-plus-tube-with-edta-anticoagulant-andd-vacutainer-plus-serum-tube 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K981013, VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE, by Becton Dickinson Vacutainer Systems https://foiadocs.com/products/fda-510k-k981318-dual-luer-lock-cap 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K981318, DUAL LUER LOCK CAP, by Baxter Healthcare Corp https://foiadocs.com/products/fda-510k-k980627-neva-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K980627, NEVA SYSTEM, by Urometrics, Inc. https://foiadocs.com/products/fda-510k-k974186-orthofix-external-fixation-screw-pin-with-hydroxyapatite-coating 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K974186, ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING, by Orthofix Srl https://foiadocs.com/products/fda-510k-k973357-coonrad-morrey-total-elbow-new-hinge-pin 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K973357, COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN, by Zimmer, Inc. https://foiadocs.com/products/fda-510k-k974018-wilson-cook-10-shot-multi-band-ligator 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K974018, WILSON-COOK 10 SHOT MULTI-BAND LIGATOR, by Wilson-Cook Medical, Inc. https://foiadocs.com/products/fda-510k-k963817-levo-mobil-lcm 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K963817, LEVO MOBIL LCM, by Levo USA https://foiadocs.com/products/fda-510k-k973951-levo-compact-easy-lce 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K973951, LEVO COMPACT-EASY LCE, by Levo USA https://foiadocs.com/products/fda-510k-k973205-wilson-cook-stricture-measuring-catheter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K973205, WILSON-COOK STRICTURE MEASURING CATHETER, by Wilson-Cook Medical, Inc. https://foiadocs.com/products/fda-510k-k970107-intubation-endoscope-and-introducer-sheath 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K970107, INTUBATION ENDOSCOPE AND INTRODUCER SHEATH, by Urohealth Systems, Inc. https://foiadocs.com/products/fda-510k-k972446-pedo-cush-pedo-cuddle 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K972446, PEDO CUSH PEDO CUDDLE, by Cavity Free Kids, Inc. https://foiadocs.com/products/fda-510k-k970864-arrow-howes-large-bore-multi-lumen-central-venous-catheters 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K970864, ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS, by Arrow Intl., Inc. https://foiadocs.com/products/fda-510k-k973500-bard-endoscopic-overtube-000307 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K973500, BARD ENDOSCOPIC OVERTUBE (#000307), by C.R. Bard, Inc. https://foiadocs.com/products/fda-510k-k972706-clinitek-microalbumin-reagent-strips 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K972706, CLINITEK MICROALBUMIN REAGENT STRIPS, by Bayer Corp. https://foiadocs.com/products/fda-510k-k971758-cauterization-smoke-evacuator 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K971758, CAUTERIZATION SMOKE EVACUATOR, by Applied Medical Technologies https://foiadocs.com/products/fda-510k-k971418-chiron-diagnostics-automated-chemiluminescence-system-asc-centaur-analyzer 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K971418, CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER, by Chiron Diagnostics Corp. https://foiadocs.com/products/fda-510k-k971873-levo-active-easy-lae 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K971873, LEVO ACTIVE-EASY LAE, by Levo USA https://foiadocs.com/products/fda-510k-k970855-clave-connector 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K970855, CLAVE CONNECTOR, by Icu Medical, Inc. https://foiadocs.com/products/fda-510k-k940954-synaptic-3000 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K940954, SYNAPTIC 3000, by The Synaptic Corp. https://foiadocs.com/products/fda-510k-k960724-bio-gide-resorbable-bilayer-membrane 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K960724, BIO-GIDE RESORBABLE BILAYER MEMBRANE, by Geistlich-Pharma https://foiadocs.com/products/fda-510k-k964518-fast-cath-transseptal-catheter-introducer 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K964518, FAST-CATH TRANSSEPTAL CATHETER INTRODUCER, by Daig Corp. https://foiadocs.com/products/fda-510k-k961608-synthes-u-s-a-polypin 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K961608, SYNTHES (U.S.A.) POLYPIN, by Synthes (Usa) https://foiadocs.com/products/fda-510k-k970418-pmt-accessory-depthalon-electrode-anchor-bolt-2103-23-xx 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K970418, PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX), by Pmt Corp. https://foiadocs.com/products/fda-510k-k970369-vista-mini-camera-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K970369, VISTA MINI CAMERA SYSTEM, by Oktas https://foiadocs.com/products/fda-510k-k964970-biomet-bone-screw 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K964970, BIOMET BONE SCREW, by Biomet, Inc. https://foiadocs.com/products/fda-510k-k970074-stanilet-freestanding-cc-infant-2000c-infant-warmer-1250c-1500c-2000d 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K970074, STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D), by Hill-Rom, Inc. https://foiadocs.com/products/fda-510k-k964853-intravia-container-empty 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K964853, INTRAVIA CONTAINER, EMPTY, by Baxter Healthcare Corp https://foiadocs.com/products/fda-510k-k963051-ercp-cannula 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K963051, ERCP CANNULA, by United States Endoscopy Group, Inc. https://foiadocs.com/products/fda-510k-k964445-octopus-tissue-stabilizer-28001-28002-28003-28004-28005-28006 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K964445, OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006), by Dlp, Inc. https://foiadocs.com/products/fda-510k-k963597-silent-night-i 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K963597, SILENT NIGHT I, by Local Silence, Inc. https://foiadocs.com/products/fda-510k-k963807-tomtec-echo-scan 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K963807, TOMTEC ECHO-SCAN, by Tomtec Imaging Systems, Inc. https://foiadocs.com/products/fda-510k-k963183-bioz-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K963183, BIOZ SYSTEM, by Cardiodynamics International Corp. https://foiadocs.com/products/fda-510k-k963816-levo-compact-lc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K963816, LEVO COMPACT LC, by Levo USA https://foiadocs.com/products/fda-510k-k962530-prolene-polypropylene-mesh-nonabsorbable-synthetic-surgical-mesh 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K962530, PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH, by ETHICON, Inc. https://foiadocs.com/products/fda-510k-k961918-multi-test-ii 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K961918, MULTI-TEST II, by Lincoln Diagnostics, Inc. https://foiadocs.com/products/fda-510k-k961725-oscar-orthosonics-system-for-cemented-arthroplasty-revision 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K961725, OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION, by C.L. Mcintosh & Assoc., Inc. https://foiadocs.com/products/fda-510k-k961878-sharps-tainer 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K961878, SHARPS-TAINER, by Winfield Industries https://foiadocs.com/products/fda-510k-k950944-ambulatory-holter-recording-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K950944, AMBULATORY (HOLTER) RECORDING SYSTEM, by Biosensor Corp. https://foiadocs.com/products/fda-510k-k960167-system-thermal-regulating-74-dwj 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K960167, SYSTEM, THERMAL REGULATING 74-DWJ, by Augustine Medical, Inc. https://foiadocs.com/products/fda-510k-k961158-suprasson-p5-booster 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K961158, SUPRASSON P5 BOOSTER, by Satelec https://foiadocs.com/products/fda-510k-k960673-osap 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K960673, OSAP, by Snorefree, Inc. https://foiadocs.com/products/fda-510k-k954828-iso-gard-hepa-filter-hme-iso-ard-hepa-filter-hme-w-port 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K954828, ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT, by Gibeck, Inc. https://foiadocs.com/products/fda-510k-k960091-enzyme-immunoassay-anti-double-stranded-dna-dsdna-test-kit 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K960091, ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT, by Helix Diagnostics, Inc. https://foiadocs.com/products/fda-510k-k953746-arrow-high-flow-fluid-adminsitration-set-w-blood-filter-extension-set 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K953746, ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SET, by Arrow Intl., Inc. https://foiadocs.com/products/fda-510k-k953967-endoscopic-catheter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K953967, ENDOSCOPIC CATHETER, by Act Medical, Inc. https://foiadocs.com/products/fda-510k-k955300-total-bilirubin-procedure 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K955300, TOTAL BILIRUBIN PROCEDURE, by Data Medical Associates, Inc. https://foiadocs.com/products/fda-510k-k953876-pentax-ultrasound-endoscope-model-fg-32ua-modification 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K953876, PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION), by Pentax Precision Instrument Corp. https://foiadocs.com/products/fda-510k-k943305-olympus-3d-surgical-endoscopy-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K943305, OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM, by Olympus America, Inc. https://foiadocs.com/products/fda-510k-k920633-pessary-flexible-silicone-nichols 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K920633, PESSARY FLEXIBLE SILICONE NICHOLS, by Bioteque America, Inc. https://foiadocs.com/products/fda-510k-k944524-snap-testing-device 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K944524, SNAP TESTING DEVICE, by Snap Laboratories, LLC https://foiadocs.com/products/fda-510k-k953235-screw-implants-grade-3-uncoated-ha-tp-k3 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K953235, SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3, by The Implant Center of the Palm Beaches https://foiadocs.com/products/fda-510k-k944957-temporary-myocardial-pacing-lead-model-6500 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K944957, TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500, by Medtronic Blood Systems, Inc. https://foiadocs.com/products/fda-510k-k934086-medrad-envision-ct-injector-and-qwik-fit-syringe 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K934086, MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE, by Medrad, Inc. https://foiadocs.com/products/fda-510k-k946147-kse-steiner-electromechanic-morcellator 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K946147, KSE STEINER ELECTROMECHANIC MORCELLATOR, by KARL STORZ Endoscopy-America, Inc. https://foiadocs.com/products/fda-510k-k952164-emi-model-fff-ia 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K952164, EMI MODEL FFF-IA, by New York Heart Instruments, Inc. https://foiadocs.com/products/fda-510k-k922688-extra-protection-polyurethane-condom 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K922688, EXTRA PROTECTION POLYURETHANE CONDOM, by Apex Medical Technologies, Inc. https://foiadocs.com/products/fda-510k-k940951-rw-resucitaire-infant-radiant-warmer 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K940951, RW RESUCITAIRE INFANT RADIANT WARMER, by Air-Shields, Inc. https://foiadocs.com/products/fda-510k-k950700-bard-bilisystem-endoscopic-retrograde-cholangiopancreatography-ercp-cannula 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K950700, BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA, by C.R. Bard, Inc. https://foiadocs.com/products/fda-510k-k951123-cavicide-surface-disinfectant-decontaminant-cleaner 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K951123, CAVICIDE SURFACE DISINFECTANT/DECONTAMINANT CLEANER, by Micro-Aseptic Products, Inc. https://foiadocs.com/products/fda-510k-k950339-ksea-steiner-electromechanic-morcellator 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K950339, KSEA STEINER ELECTROMECHANIC MORCELLATOR, by KARL STORZ Endoscopy-America, Inc. https://foiadocs.com/products/fda-510k-k950729-olympus-pr-23q-disposable-cannula-ball-tip 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K950729, OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP), by Olympus America, Inc. https://foiadocs.com/products/fda-510k-k942694-stability-system-110v-model-945-300-stability-system-220v-model-945-302 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K942694, STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302, by Biodex Medical Systems, Inc. https://foiadocs.com/products/fda-510k-k941507-themo-flo-system-3-laparoscopic-hysteroscopic-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K941507, THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM, by Sanese Medical Corp. https://foiadocs.com/products/fda-510k-k940852-chief-standup-wheelchair 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K940852, CHIEF STANDUP WHEELCHAIR, by Redman, Inc. https://foiadocs.com/products/fda-510k-k935094-balloon-dilation-catheter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K935094, BALLOON DILATION CATHETER, by Wilson-Cook Medical, Inc. https://foiadocs.com/products/fda-510k-k926139-cathlink-20-titanium-port-w-att-polyurethane-cath 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K926139, CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH, by Bard Access Systems, Inc. https://foiadocs.com/products/fda-510k-k941327-crosstex-self-sealing-sterilization-pouch 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K941327, CROSSTEX SELF-SEALING STERILIZATION POUCH, by Cross Country Paper Products Corp. https://foiadocs.com/products/fda-510k-k942902-sharps-tainer-small-opening-w-needle-remover 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K942902, SHARPS-TAINER SMALL OPENING W/NEEDLE REMOVER, by Winfield Co., Inc. https://foiadocs.com/products/fda-510k-k942823-mahe-instruments 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K942823, MAHE INSTRUMENTS, by Mahe Intl., Inc. https://foiadocs.com/products/fda-510k-k944254-oktas-stereo-viewing-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K944254, OKTAS STEREO VIEWING SYSTEM, by Oktas https://foiadocs.com/products/fda-510k-k940189-coil-positioner-set 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K940189, COIL POSITIONER SET, by Cook, Inc. https://foiadocs.com/products/fda-510k-k942821-mahe-instruments 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K942821, MAHE INSTRUMENTS, by Mahe-Medizintechnik https://foiadocs.com/products/fda-510k-k942901-sharps-tainer-large-opening 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K942901, SHARPS-TAINER LARGE OPENING, by Winfield Co., Inc. https://foiadocs.com/products/fda-510k-k942903-sharps-tainer-small-opening 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K942903, SHARPS-TAINER SMALL OPENING, by Winfield Co., Inc. https://foiadocs.com/products/fda-510k-k941691-revo-rotator-cuff-repair-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K941691, REVO ROTATOR CUFF REPAIR SYSTEM, by Linvatec Corp. https://foiadocs.com/products/fda-510k-k942054-sharps-tainer 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K942054, SHARPS-TAINER, by Winfield Industries https://foiadocs.com/products/fda-510k-k942819-trocar-with-shield 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K942819, TROCAR WITH SHIELD, by Mahe-Medizintechnik https://foiadocs.com/products/fda-510k-k942533-novalens-novawet-perception-and-vanguard 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K942533, NOVALENS/NOVAWET PERCEPTION AND VANGUARD, by Ocutec Corporation, Inc. https://foiadocs.com/products/fda-510k-k933768-coagulator-laparoscopic-lunipolar-accessories 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K933768, COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES, by Mahe-Medizintechnik https://foiadocs.com/products/fda-510k-k942044-bard-endoscopic-overtube 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K942044, BARD ENDOSCOPIC OVERTUBE, by C.R. Bard, Inc. https://foiadocs.com/products/fda-510k-k933094-insufflator-tubing-kit-w-filter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K933094, INSUFFLATOR TUBING KIT W/FILTER, by Inman Medical Corp. https://foiadocs.com/products/fda-510k-k940187-envoy-guiding-catheter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K940187, ENVOY GUIDING CATHETER, by Cordis Neurovascular, Inc. https://foiadocs.com/products/fda-510k-k935442-mahe-instruments 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K935442, MAHE INSTRUMENTS, by Mahe-Medizintechnik https://foiadocs.com/products/fda-510k-k931588-sutter-proximal-interphalangeal-joint 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K931588, SUTTER PROXIMAL INTERPHALANGEAL JOINT, by Sutter Corp. https://foiadocs.com/products/fda-510k-k914145-dsd-91tm-disinfector-for-flexible-endoscopes 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K914145, DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES, by Medivators, Inc. https://foiadocs.com/products/fda-510k-k933121-microbiological-culture-media-chocolate-agar 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K933121, MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR, by Bioclinical Systems, Inc. https://foiadocs.com/products/fda-510k-k931621-acufex-pro-pac-and-iso-pac 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K931621, ACUFEX PRO-PAC AND ISO-PAC, by Acufex Microsurgical, Inc. https://foiadocs.com/products/fda-510k-k935674-lifepak-9-defibrillator-monitor 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K935674, LIFEPAK 9 DEFIBRILLATOR/MONITOR, by Physio-Control Corp. https://foiadocs.com/products/fda-510k-k931374-affirm-vpiii-microbial-identification-test 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K931374, AFFIRM VPIII MICROBIAL IDENTIFICATION TEST, by Microprobe Corp. https://foiadocs.com/products/fda-510k-k930622-amplatz-guidewires 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K930622, AMPLATZ GUIDEWIRES, by Meadox Medicals, Div. Boston Scientific Corp. https://foiadocs.com/products/fda-510k-k925794-trace-microprotein-reagent 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K925794, TRACE MICROPROTEIN REAGENT, by Trace America, Inc. https://foiadocs.com/products/fda-510k-k923160-3dscope 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K923160, 3DSCOPE, by American Surgical Technologies Corp. https://foiadocs.com/products/fda-510k-k921300-model-pc-argon-ion-laser 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K921300, MODEL PC ARGON ION LASER, by Hgm Medical Laser Systems, Inc. https://foiadocs.com/products/fda-510k-k922457-affirm-vp-microbial-id-test-for-trichomonas-vagina 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K922457, AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA, by Microprobe Corp. https://foiadocs.com/products/fda-510k-k911144-mf-500-modification 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K911144, MF-500, MODIFICATION, by Elcot, Inc. https://foiadocs.com/products/fda-510k-k913083-bi-temp-temperature-monitor-tm-201d 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K913083, BI-TEMP TEMPERATURE MONITOR TM-201D, by Respiratory Support Products, Inc. https://foiadocs.com/products/fda-510k-k913569-compac-a-elite-a-elite-a-plus-surgica-a 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K913569, COMPAC A, ELITE A, ELITE A PLUS, SURGICA A, by Hgm Medical Laser Systems, Inc. https://foiadocs.com/products/fda-510k-k912628-air-argon-ion-lasers-various-models 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K912628, AIR ARGON ION LASERS VARIOUS MODELS, by Hgm Medical Laser Systems, Inc. https://foiadocs.com/products/fda-510k-k910272-hgm-combination-nd-yag-solid-state-green 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K910272, HGM COMBINATION ND:YAG & SOLID STATE GREEN, by Hgm Medical Laser Systems, Inc. https://foiadocs.com/products/fda-510k-k912438-models-5-8-20-20s-argon-ion-lasers 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K912438, MODELS 5,8,20,20S ARGON ION LASERS, by Hgm Medical Laser Systems, Inc. https://foiadocs.com/products/fda-510k-k910769-surgitekr-ercp-contrast-media-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K910769, SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM, by Surgitek Medical Engineering Corp. https://foiadocs.com/products/fda-510k-k910602-hgm-argon-ion-solid-light-laser-for-dentistry 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K910602, HGM ARGON ION & SOLID LIGHT LASER FOR DENTISTRY, by Hgm Medical Laser Systems, Inc. https://foiadocs.com/products/fda-510k-k904573-pentax-ultrasound-endoscope-model-fg-32ua 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K904573, PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA, by Pentax Precision Instrument Corp. https://foiadocs.com/products/fda-510k-k910898-surgicatm-h 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K910898, SURGICA(TM) H, by Hgm Medical Laser Systems, Inc. https://foiadocs.com/products/fda-510k-k910124-low-vision-enhancement-system-lves 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K910124, LOW VISION ENHANCEMENT SYSTEM (LVES), by Triangle Investments https://foiadocs.com/products/fda-510k-k901337-hilal-embolization-microcoiltm 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K901337, HILAL EMBOLIZATION MICROCOIL(TM), by Cook, Inc. https://foiadocs.com/products/fda-510k-k902149-fresenius-delmed-90-2-peritoneal-dialysis-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K902149, FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM, by Fresenius/Delmed, Inc. https://foiadocs.com/products/fda-510k-k903654-liss-cranial-stimulator-model-sbl202-b 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K903654, LISS CRANIAL STIMULATOR MODEL SBL202-B, by Medical Consultants Intl. , Ltd. https://foiadocs.com/products/fda-510k-k903390-medrad-mark-v-plus-injector 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K903390, MEDRAD MARK V-PLUS INJECTOR, by Medrad, Inc. https://foiadocs.com/products/fda-510k-k902954-ober2-monitor-eye-movement-ophthalmic 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K902954, OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC), by Permobil AB https://foiadocs.com/products/fda-510k-k901449-vacutainer-plus-with-hemogard-closure 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K901449, VACUTAINER PLUS WITH HEMOGARD CLOSURE, by Bd Becton Dickinson Vacutainer Systems Preanalytic https://foiadocs.com/products/fda-510k-k900770-home-urodata-systemtm 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K900770, HOME URODATA SYSTEM(TM), by Biodan Medical Systems, Ltd. https://foiadocs.com/products/fda-510k-k896422-burron-ambulatory-drug-delivery-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K896422, BURRON AMBULATORY DRUG DELIVERY SYSTEM, by Burron Medical, Inc. https://foiadocs.com/products/fda-510k-k900129-modified-auto-suture-endoscopic-gia-surg-stapler 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K900129, MODIFIED AUTO SUTURE ENDOSCOPIC GIA SURG. STAPLER*, by United States Surgical, A Division of Tyco Healthc https://foiadocs.com/products/fda-510k-k895640-magnum-plus-latex-condom-w-spermicidal-lubricant 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K895640, MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT, by Armkel, LLC https://foiadocs.com/products/fda-510k-k894949-sqa 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K894949, SQA, by United Medical Systems, Inc. https://foiadocs.com/products/fda-510k-k895766-asnis-ii-guided-bone-screw 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K895766, ASNIS II GUIDED BONE SCREW, by Howmedica Corp. https://foiadocs.com/products/fda-510k-k884709-endoscopes-access-sclerotherapy-transbronchial 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K884709, ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL), by Primrose Medical, Inc. https://foiadocs.com/products/fda-510k-k892364-kaltostattm-wound-dressing 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K892364, KALTOSTAT(TM) WOUND DRESSING, by Calgon Vestal Div. https://foiadocs.com/products/fda-510k-k893396-an-alternative-direct-bonding-ortho-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K893396, AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM, by American Orthodontics https://foiadocs.com/products/fda-510k-k890749-cbc-tech-tm-hematology-control-multiple 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K890749, CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE, by R&D Systems, Inc. https://foiadocs.com/products/fda-510k-k881765-cts-3060-automated-semen-analyzer 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K881765, CTS-3060 AUTOMATED SEMEN ANALYZER, by Motion Analysis Corp. https://foiadocs.com/products/fda-510k-k883665-coonrad-iii-total-elbow 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K883665, COONRAD III TOTAL ELBOW, by Zimmer, Inc. https://foiadocs.com/products/fda-510k-k883414-laryngoscope-blades 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K883414, LARYNGOSCOPE BLADES, by Truphatek, Ltd. https://foiadocs.com/products/fda-510k-k881609-sitzmarks 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K881609, SITZMARKS, by Lafayette Pharmacal, Inc. https://foiadocs.com/products/fda-510k-k881577-modified-selective-streptococcus-agar 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K881577, MODIFIED SELECTIVE STREPTOCOCCUS AGAR, by Acumedia Manufacturers, Inc. https://foiadocs.com/products/fda-510k-k871242-reverse-osmosis-water-purification-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K871242, REVERSE OSMOSIS WATER PURIFICATION SYSTEM, by Medro Systems, Inc. https://foiadocs.com/products/fda-510k-k872849-sperm-select-additional-indication 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K872849, SPERM-SELECT ADDITIONAL INDICATION, by Pharmacia, Inc. https://foiadocs.com/products/fda-510k-k872018-kotex-stick-tampons-regular-and-super 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K872018, KOTEX STICK TAMPONS, REGULAR AND SUPER, by Kimberly-Clark Corp. https://foiadocs.com/products/fda-510k-k863815-electroconvulsive-therapy-device-model-mf-1000 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K863815, ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000, by Elcot, Inc. https://foiadocs.com/products/fda-510k-k864492-swanson-titanium-great-toe-implant 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K864492, SWANSON TITANIUM GREAT TOE IMPLANT, by Dow Corning Wright https://foiadocs.com/products/fda-510k-k864218-procon 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K864218, PROCON, by Healthcare Management Systems https://foiadocs.com/products/fda-510k-k864224-abbott-spectrum-glucose-reagent 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K864224, ABBOTT SPECTRUM GLUCOSE REAGENT, by Abbott Laboratories https://foiadocs.com/products/fda-510k-k860467-electroshock-unit-neurology-model-b-25 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K860467, ELECTROSHOCK UNIT NEUROLOGY MODEL B-25, by Medcraft Corp. https://foiadocs.com/products/fda-510k-k854903-gordon-diagnostic-system-model-i 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K854903, GORDON DIAGNOSTIC SYSTEM MODEL I, by Clinical Diagnostics, Inc. https://foiadocs.com/products/fda-510k-k861307-disposable-needle-counter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K861307, DISPOSABLE NEEDLE COUNTER, by Anago, Inc. https://foiadocs.com/products/fda-510k-k861316-disposable-needle-counter-20-240 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K861316, DISPOSABLE NEEDLE COUNTER (20-240), by Anago, Inc. https://foiadocs.com/products/fda-510k-k851422-s-rom-135-femoral-stem-collarpart-of-s-rom-hip 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K851422, S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIP, by Joint Medical Products Corp. https://foiadocs.com/products/fda-510k-k852069-mecta-ect-device-models-sr-jr 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K852069, MECTA ECT DEVICE MODELS SR & JR, by Mecta Corp. https://foiadocs.com/products/fda-510k-k845036-tissue-expanders-for-reconstruc-surgery-3600 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K845036, TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600, by Progress Mankind Technology https://foiadocs.com/products/fda-510k-k845018-davol-ercp-cannula 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K845018, DAVOL ERCP CANNULA, by C.R. Bard, Inc. https://foiadocs.com/products/fda-510k-k843263-arrow-johans-ecg-adaptor 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K843263, ARROW-JOHANS ECG ADAPTOR, by Arrow Intl., Inc. https://foiadocs.com/products/fda-510k-k183685-system-nuclear-magnetic-resonance-imaging 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K183685, O-Scan, by Esaote, S.p.A. https://foiadocs.com/products/anda-211287-approval-letter-routing-sheet-crl 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-510k-k202182-zoom-71-55-45-35-reperfusion-catheters-zoom-aspiration-tubing 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K202182, ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing, by Imperative Care, Inc. https://foiadocs.com/products/fda-510k-k232053-simplesense-bp-simplesense-bp-software-application 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K232053, SimpleSense-BP, SimpleSense-BP Software Application, by Nanowear, Inc. https://foiadocs.com/products/fda-510k-k131845-acumed-anatomic-radial-head-system-acumed-anatomic-radial-head-long-stems-acumed-arh-slide-loc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131845, ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC, by Acumed, LLC https://foiadocs.com/products/fda-510k-k223073-alio 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K223073, Alio, by Alio, Inc. https://foiadocs.com/products/nda-208232-orphan-drug-designation-letter-for-mycapssa-6-17-10 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-510k-k760462-electrical-shock-device 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K760462, ELECTRICAL SHOCK DEVICE, by Edward V. Kaufholz, Sr. https://foiadocs.com/products/fda-510k-k770276-electrotherapy-apparatus-e-t-720 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K770276, ELECTROTHERAPY APPARATUS E.T. 720, by Fort & Assoc. https://foiadocs.com/products/fda-510k-k771203-disp-hypodermic-needle 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K771203, DISP. HYPODERMIC NEEDLE, by Terumo America, Inc. https://foiadocs.com/products/fda-510k-k781318-dynatron-406-electrotherapy-apparatus 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K781318, DYNATRON 406 ELECTROTHERAPY APPARATUS, by General Theraphysical, Inc. https://foiadocs.com/products/fda-510k-k791963-usci-mullins-transseptal-catheter-intro 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K791963, USCI MULLINS TRANSSEPTAL CATHETER INTRO., by C.R. Bard, Inc. https://foiadocs.com/products/fda-510k-k801969-asnis-guided-screw-systems 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K801969, ASNIS GUIDED SCREW SYSTEMS, by Howmedica Corp. https://foiadocs.com/products/fda-510k-k802443-e-r-c-p-cannula-product 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K802443, E.R.C.P. CANNULA PRODUCT, by Mill-Rose Laboratory https://foiadocs.com/products/fda-510k-k810428-vicryl 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K810428, VICRYL, by ETHICON, Inc. https://foiadocs.com/products/fda-510k-k811742-hemotherm-model-400 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K811742, HEMOTHERM MODEL 400, by Cincinnati Sub-Zero https://foiadocs.com/products/fda-510k-k813388-hemodialysate 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K813388, HEMODIALYSATE, by Edlaw Pharmaceuticals, Inc. https://foiadocs.com/products/fda-510k-k813639-series-400-disposable-temperature-probe 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K813639, SERIES 400 DISPOSABLE TEMPERATURE PROBE, by Yellow Springs Instrument Co., Inc. https://foiadocs.com/products/fda-510k-k820431-e-r-c-p-cannulas 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K820431, E.R.C.P. CANNULAS, by American Endoscopy, Inc. https://foiadocs.com/products/fda-510k-k822735-sure-count-disposable-needle-counter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K822735, SURE-COUNT DISPOSABLE NEEDLE COUNTER, by Geneva Laboratories, Inc. https://foiadocs.com/products/fda-510k-k830332-budde-halo-retractor 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K830332, BUDDE-HALO RETRACTOR, by Ohio Medical Instrument Co., Inc. https://foiadocs.com/products/fda-510k-k833417-endoscopic-retrograde 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K833417, ENDOSCOPIC RETROGRADE, by Microvasive https://foiadocs.com/products/fda-510k-k834414-ercp-cannula 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K834414, ERCP CANNULA, by Hobbs Medical, Inc. https://foiadocs.com/products/fda-510k-k840207-double-single-tantalum-clips 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K840207, DOUBLE & SINGLE TANTALUM CLIPS, by Storz Instrument Co. https://foiadocs.com/products/fda-510k-k842262-pird-y 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K842262, PIRD-Y, by Pirdy, Inc. https://foiadocs.com/products/fda-510k-k842607-infant-apnea-bed-stimulator-aa-010 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K842607, INFANT APNEA BED STIMULATOR AA-010, by Alpha Medical Systems https://foiadocs.com/products/fda-510k-k843146-micro-temp-pumps-micro-temp-pads 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K843146, MICRO-TEMP PUMPS & MICRO-TEMP PADS, by Seabrook Medical Systems, Inc. https://foiadocs.com/products/fda-510k-k120431-halo90-ultra-ablation-catheter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120431, HALO90 ULTRA ABLATION CATHETER, by Barrx Medical, Inc. https://foiadocs.com/products/fda-510k-k190815-brainscope-tbi 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190815, BrainScope TBI, by Brainscope Company, Inc. https://foiadocs.com/products/fda-510k-k200125-thermoforming-sheet-materials 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200125, Thermoforming Sheet Materials, by Erkodent Erich Kopp GmbH https://foiadocs.com/products/fda-510k-k200947-inmode-system-with-the-morhpeus8-applicators 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200947, InMode System with the Morhpeus8 Applicators, by InMode , Ltd. https://foiadocs.com/products/fda-510k-k202087-dixi-medical-microdeep-micro-macro-depth-electrodes 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K202087, DIXI Medical Microdeep Micro-Macro Depth Electrodes, by Dixi Medical https://foiadocs.com/products/fda-510k-k202145-bigfoot-unity-diabetes-management-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K202145, Bigfoot Unity Diabetes Management System, by Bigfoot Biomedical, Inc. https://foiadocs.com/products/fda-510k-k213863-everion-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K213863, Everion+ System, by Biofourmis Singapore Pte., Ltd. https://foiadocs.com/products/fda-510k-k221943-embedmed 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K221943, EmbedMed, by 3D Lifeprints UK , Ltd. https://foiadocs.com/products/fda-510k-k222067-sc-hemodialysis-device-sc-dialysate-cartridge-sc-blood-tube-set 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K222067, SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set, by Quanta Dialysis Technologies, Ltd. https://foiadocs.com/products/fda-510k-k222296-articul-eze-ceramic-heads 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K222296, ARTICUL/EZE Ceramic Heads, by Depuy Ireland UC https://foiadocs.com/products/fda-510k-k222318-fresenius-liberty-select-cycler 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K222318, Fresenius Liberty Select Cycler, by Fresenius Medical Care Renal Therapies Group, LLC https://foiadocs.com/products/fda-510k-k222743-route-92-medical-full-length-070-access-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K222743, Route 92 Medical Full Length 070 Access System, by Route 92 Medical, Inc. https://foiadocs.com/products/fda-510k-k231914-nurochek-ii-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K231914, Nurochek-II System, by Headsafe Mfg Pty, Ltd. https://foiadocs.com/products/fda-510k-k232380-t-slim-x2-insulin-pump-with-interoperable-technology 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K232380, t:slim X2 Insulin Pump with Interoperable Technology, by Tandem Diabetes Care, Inc. https://foiadocs.com/products/fda-510k-k232852-cross-vascular-rf-transseptal-needle-cross-vascular-connection-cable 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K232852, Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable, by Cross Vascular, Inc. https://foiadocs.com/products/fda-510k-k240098-defendo-single-use-valve-kit-aw-s-valves-2pc-for-olympus-eus-00711900 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K240098, DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900), by STERIS Corporation https://foiadocs.com/products/fda-510k-k231337-endeavorrx 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K231337, EndeavorRx, by Akili Interactive Labs, Inc. https://foiadocs.com/products/fda-510k-k223873-boppli-infant-blood-pressure-monitor 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K223873, Boppli Infant Blood Pressure Monitor, by Pyrames, Inc. https://foiadocs.com/products/fda-510k-k223290-commandep-data-manager-pc-dpc02-commandep-hmd-hmd02 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K223290, CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02), by Sentiar, Inc. https://foiadocs.com/products/fda-510k-k222032-neuromark-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K222032, NEUROMARK System, by Neurent Medical https://foiadocs.com/products/fda-510k-k220281-multifiltratepro-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K220281, multiFiltratePRO System, by Fresenius Medical Care Renal Therapies Group, LLC https://foiadocs.com/products/fda-510k-k212224-tracstar-ldp-large-distal-platform-zoom-88-large-distal-platform 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K212224, TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform, by Imperative Care, Inc. https://foiadocs.com/products/fda-510k-k192651-zaga-zygomatic-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192651, ZAGA Zygomatic System, by Southern Implants (Pty), Ltd. https://foiadocs.com/products/fda-510k-k190962-bella-mu 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190962, Bella-mu, by U-Needle B.V. https://foiadocs.com/products/fda-510k-k190718-zygomatic-implants 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190718, Zygomatic Implants, by Jjgc Industria E Comercio DE Materiais Dentarios S.A. https://foiadocs.com/products/fda-510k-k183241-brainscope-tbi-model-ahead-400 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K183241, BrainScope TBI (Model: Ahead 400), by Brainscope Company, Inc. https://foiadocs.com/products/fda-510k-k183069-nobelzygoma-0 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K183069, NobelZygoma 0°, by Nobel Biocare AB https://foiadocs.com/products/fda-510k-k170366-laser-peripherals-llc-family-of-bare-laser-fibers 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K170366, Laser Peripherals, LLC Family of Bare Laser Fibers, by Laser Peripherals, LLC https://foiadocs.com/products/fda-510k-k170155-ek12-algorithm 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K170155, EK12 Algorithm, by Ge Medical Systems Information Technologies, Inc. https://foiadocs.com/products/fda-510k-k161354-melody-remote-control-system-for-ultrasound-probe 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161354, MELODY, Remote Control System for Ultrasound Probe, by Adecho Tech https://foiadocs.com/products/fda-510k-k153064-blue-sky-bio-zygomatic-implant-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153064, Blue Sky Bio Zygomatic Implant System, by Blue Sky Bio, LLC https://foiadocs.com/products/fda-510k-k152869-lipiview-ii-ocular-surface-interferometer 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152869, LipiView II Ocular Surface Interferometer, by Tearscience, Inc. https://foiadocs.com/products/fda-510k-k150621-osteoselect-plus-demineralized-bone-matrix-putty 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150621, OsteoSelect PLUS Demineralized Bone Matrix Putty, by Bacterin International, Inc. https://foiadocs.com/products/fda-510k-k124018-amia-automated-pd-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K124018, AMIA AUTOMATED PD SYSTEM, by Deka Research & Development Corp. https://foiadocs.com/products/fda-510k-k030874-ge-3-0t-signa-infinity-twinspeed-with-excite-mr-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K030874, GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM, by General Electric Co. https://foiadocs.com/products/fda-510k-k111610-trilogy-series-ventilator-with-oximetry 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K111610, TRILOGY SERIES VENTILATOR WITH OXIMETRY, by Respironics, Inc. https://foiadocs.com/products/fda-510k-k113053-bipap-a-30-ventilatory-support-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K113053, BIPAP A 30 VENTILATORY SUPPORT SYSTEM, by Respironics, Inc. https://foiadocs.com/products/fda-510k-k121623-bipap-a-40-ventilatory-support-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121623, BIPAP A 40 VENTILATORY SUPPORT SYSTEM, by Respironics, Inc. https://foiadocs.com/products/fda-510k-k161756-syncvision-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161756, SyncVision System, by Volcano Corporation https://foiadocs.com/products/fda-510k-k162383-cadwell-sierra-summit-cadwell-sierra-ascent 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K162383, Cadwell Sierra Summit, Cadwell Sierra Ascent, by Cadwell Industries, Inc. https://foiadocs.com/products/fda-510k-k182630-omnipod-insulin-management-system-omnipod-dash-insulin-management-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182630, Omnipod Insulin Management System, Omnipod DASH Insulin Management System, by Insulet Corporation https://foiadocs.com/products/fda-510k-k833122-burlington-antimicrobial-stockineette 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K833122, BURLINGTON ANTIMICROBIAL STOCKINEETTE, by Balfour, Inc. https://foiadocs.com/products/fda-510k-k904870-modified-new-jersey-femoral-hip-resurfacing-compon 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K904870, MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON, by Endotec, Inc. https://foiadocs.com/products/fda-510k-k952683-apex-medical-corp-portable-interferential-stimulation-device 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K952683, APEX MEDICAL CORP. PORTABLE INTERFERENTIAL STIMULATION DEVICE, by Wholesale Medical Imports, Inc. https://foiadocs.com/products/fda-510k-k081311-powerport-implanted-port-with-groshong-catheter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K081311, POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER, by C.R. Bard, Inc. https://foiadocs.com/products/fda-510k-k100451-gamcath-high-flow-dolphin 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100451, Gamcath High Flow Dolphin Ms-Gdhc-1315 A; and Ms-Gdhc-1315j A, Gamcath High Flow Dolphin Ms-Gdhc-1320 A; and Ms-Gdhc-132, by Gambro Renal Products, Inc. https://foiadocs.com/products/fda-510k-k073423-mri-powerport-implanted-port-with-9-6-fr-silicone-catheter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K073423, MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER, by C.R. Bard, Inc. https://foiadocs.com/products/fda-510k-k932184-sterile-lemaitre-glow-n-tell-tape 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K932184, STERILE LEMAITRE GLOW 'N TELL TAPE, by Vascutech, Inc. https://foiadocs.com/products/fda-nda-214755-review-files-for-the-supplemental-nda-application-for-lumryz 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-510k-cycler-sets-mod-5c4143-5c4144-5c4145-travenol-laboratories-s-a 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K791899, CYCLER SETS MOD. #5C4143, 5C4144, 5C4145, by Travenol Laboratories, S.A. https://foiadocs.com/products/fda-510k-guardian-peel-pouches-kimberly-clark-corp 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K803293, GUARDIAN PEEL POUCHES, by Kimberly-Clark Corp. https://foiadocs.com/products/fda-510k-travelaire-b-f-medical-products-inc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K811404, TRAVELAIRE, by B & F Medical Products, Inc. https://foiadocs.com/products/fda-510k-uni-set-inhalation-therapy-equipment-co 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K820128, UNI-SET, by Inhalation Therapy Equipment, Co. https://foiadocs.com/products/fda-510k-hickman-plastic-subcutaneous-port-c-r-bard-inc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K873213, HICKMAN PLASTIC SUBCUTANEOUS PORT, by C.R. Bard, Inc. https://foiadocs.com/products/fda-510k-cpap-mask-devilbiss-health-care-inc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K894690, CPAP MASK, by Devilbiss Health Care, Inc. https://foiadocs.com/products/fda-510k-plastic-low-profile-subcutaneous-port-bard-access-systems-inc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K924250, PLASTIC LOW PROFILE SUBCUTANEOUS PORT, by Bard Access Systems, Inc. https://foiadocs.com/products/fda-510k-puritan-bennett-nasal-cpap-mask-puritan-bennett 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K942246, PURITAN-BENNETT NASAL CPAP MASK, by Puritan-Bennett https://foiadocs.com/products/fda-510k-steriking-sterilization-pouches-rolls-wihuri-oy 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K953776, STERIKING STERILIZATION POUCHES & ROLLS, by Wihuri OY https://foiadocs.com/products/fda-510k-ultraset-3l-capd-disposable-disconnect-y-set-models-5c4366-5c4493-baxter-healthcare-corp 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K961825, ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493, by Baxter Healthcare Corp https://foiadocs.com/products/fda-510k-dual-slim-port-implanted-port-0654970-0654940-c-r-bard-inc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K964066, DUAL SLIM PORT IMPLANTED PORT (0654970/0654940), by C.R. Bard, Inc. https://foiadocs.com/products/fda-510k-heartport-thoracic-trocar-heartport-inc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K964302, HEARTPORT THORACIC TROCAR, by Heartport, Inc. https://foiadocs.com/products/fda-510k-kimberly-clark-self-seal-pouch-for-low-temperature-sterilization-kimberly-clark-corp 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K973827, KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION, by Kimberly-Clark Corp. https://foiadocs.com/products/fda-510k-vessel-dilator-fetzer-medical-gmbh-co-kg 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K163524, Vessel Dilator, by Fetzer Medical GmbH & Co. KG https://foiadocs.com/products/fda-510k-customizedbone-service-regulatory-and-clinical-research-institute-inc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K193547, CustomizedBone Service, by Fin-Ceramica Faenza S.P.A. https://foiadocs.com/products/fda-510k-sherpapak-lung-preservation-system-sherpapak-liver-transport-system-northstar-biomedical-associates 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192869, SherpaPak Lung Preservation System , SherpaPak Liver Transport System, by Pragonix Technologies https://foiadocs.com/products/fda-510k-orion-lnteracoustics-a-s 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200529, Orion, by Interacoustics A/S https://foiadocs.com/products/fda-510k-penumbra-system-reperfusion-catheter-red-62-penumbra-inc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203440, Penumbra System (Reperfusion Catheter RED 62), by Penumbra, Inc. https://foiadocs.com/products/fda-510k-kls-martin-ips-preprosthetic-kls-martin-l-p 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K210228, KLS Martin IPS Preprosthetic, by KLS-Martin L.P. https://foiadocs.com/products/fda-510k-mightysat-otc-masimo-corporation 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K214115, MightySat -OTC, by Masimo Corporation https://foiadocs.com/products/fda-510k-lapbox-tissue-containment-removal-system-promedoss-inc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K221365, LapBox Tissue Containment Removal System, by Ark Surgical, Ltd. https://foiadocs.com/products/fda-510k-conduit-cages-fibergraft-bg-putty-mcra-llc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K222276, CONDUIT Cages; FIBERGRAFT BG Putty, by Depuy Spine https://foiadocs.com/products/fda-510k-smartcardia-7l-platform-steurer-consulting-group-llc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K231276, SmartCardia 7L Platform, by Smartcardia SA https://foiadocs.com/products/fda-510k-q-pad-test-system-hyman-phelps-mcnamara-p-c 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K231465, Q-Pad Test System, by Qurasense https://foiadocs.com/products/fda-510k-avita-nasal-aspirator-model-ns1-series-avita-corporation 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K090379, AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES, by Avita Corporation https://foiadocs.com/products/fda-510k-poly-fit-absorbing-and-high-absorbing-antimicrobial-dressings-polyremedy-inc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092351, POLY FIT + ABSORBING AND HIGH ABSORBING ANTIMICROBIAL DRESSINGS, by Polyremedy, Inc. https://foiadocs.com/products/fda-510k-instrumed-vessel-dilators-model-65-7xx-65-9xxx-66-1xxx-65-7048-65-7054-instrumed-international-inc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100518, INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054, by Instrumed International, Inc. https://foiadocs.com/products/fda-510k-stratify-jcv-dxselect-focus-diagnostics-inc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120986, STRATIFY JCV DXSELECT, by Focus Diagnostics, Inc. https://foiadocs.com/products/fda-510k-video-system-center-olympus-medical-systems-corp 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122831, VIDEO SYSTEM CENTER, by Olympus Medical Systems Corp. https://foiadocs.com/products/fda-510k-powerport-clearvue-slim-implantable-port-c-r-bard-inc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122899, POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, by C.R. Bard, Inc. https://foiadocs.com/products/fda-510k-flexiva-sf-side-firing-single-use-laser-fiber-third-party-review-group-llc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140503, FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER, by Boston Scientific https://foiadocs.com/products/fda-510k-specialty-55-multifocal-methafilcon-a-soft-hydrophilic-contact-lenses-for-daily-wear-clearlab-pte-ltd 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K003833, SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES FOR DAILY WEAR, by Clearlab Pte , Ltd. https://foiadocs.com/products/fda-510k-bardport-x-port-isp-port-c-r-bard-inc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K022983, BARDPORT X-PORT ISP PORT, by C.R. Bard, Inc. https://foiadocs.com/products/fda-510k-devilbiss-5-liter-compact-oxygen-concentrator-model-525-series-sunrise-medical 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K071397, DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES, by Sunrise Medical https://foiadocs.com/products/fda-510k-titanium-powerport-isp-implanted-port-c-r-bard-inc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K072215, TITANIUM POWERPORT ISP IMPLANTED PORT, by C.R. Bard, Inc. https://foiadocs.com/products/fda-510k-spermcheck-vasectomy-princeton-biomeditech-corp 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K073039, SPERMCHECK VASECTOMY, by Princeton BioMeditech Corp. https://foiadocs.com/products/fda-fcn-694-submitted-by-lubrizol-ltd 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/submissions-to-fda-from-eyepoint-pharmaceuticals-inc-regarding-the-02-2024-inspection 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-510k-k032041-distal-perfusion-catheter-1-5-cm-and-2-5cm 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K032041, DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM), by LeMaitre Vascular, Inc. https://foiadocs.com/products/fda-fcn-1805-submitted-by-solvay-specialty-polymers-usa-llc 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-fcn-2025-submitted-by-eastman-chemical-company 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/anda-217248-approval-routing-summary-alkem-labs 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-anda-206210-approval-routing-summary-actavis-laboratories-fl-inc 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-anda-215561-approval-routing-summary-for-lupin 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-nda-208232-cder-s-dge-divisions-response-to-oopd-regarding-mycapssa-dated-4-5-24 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-510k-k223609-revcore-thrombectomy-catheter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K223609, RevCore™ Thrombectomy Catheter., by Inari Medical, Inc. https://foiadocs.com/products/fda-nda-009193-cogentin-merck-03-05-1954 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-nda-012015-cogentin-epic-pharma-llc-12-21-1959 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-nda-012575-actifed-w-codeine-glaxosmithkline-01-00-1900 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-nda-014134-protopam-chloride-baxter-hlthcare-corp-03-11-1964 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-nda-016798-sinequan-pfizer-09-23-1969 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-nda-018687-normodyne-schering-08-01-1984 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-nda-018932-revia-teva-womens-11-20-1984 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-nda-020007-zofran-preservative-free-sandoz-01-04-1991 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-nda-020103-zofran-sandoz-12-31-1992 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-nda-050684-zosyn-wyeth-pharms-10-22-1993 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-bla-103705-rituxan-genentech-11-26-1997 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-nda-201094-glydo-sagent-pharms-inc-04-28-2014 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-anda-206873-glatiramer-acetate-synthon-pharms-inc-09-25-2024 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-anda-207957-fluticasone-propionate-hikma-05-26-2016 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-nda-209637-ozempic-novo-12-05-2017 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-nda-209988-furoscix-scpharmaceuticals-10-07-2022 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-anda-210317-octreotide-acetate-teva-pharms-usa-inc-12-05-2023 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-anda-214348-bupivacaine-liposome-hengrui-pharma-07-01-2024 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-nda-215256-wegovy-novo-06-04-2021 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-nda-215808-ketamine-hydrochloride-fresenius-kabi-usa-01-13-2023 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-nda-216354-austedo-xr-teva-02-17-2023 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-anda-216935-prednisolone-acetate-lupin-ltd-08-02-2024 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-anda-217250-eribulin-mesylate-baxter-hlthcare-corp-10-01-2024 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-anda-218281-eribulin-mesylate-jiangxi-qingfeng-06-28-2024 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-anda-013601-mucomyst-apothecon-09-14-1963 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-nda-215866-mounjaro-autoinjector-eli-lilly-and-co-05-13-2022 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-anda-207382-approval-routing-summary-zydus-pharmaceuticals 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-anda-205976-approval-routing-summary-endo 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-anda-217231-approval-routing-summary-dr-reddy-s 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/food-contact-notification-fcn-2197 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-anda-214850-eribulin-mesylate-long-grove-pharms 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-anda-212299-doxorubicin-hydrochloride-liposomal-zydus-lifesciences-09-10-2020 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-nda-070292-carbachol-pharmafair 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/510k-file-auris-health-monarch-platform-urology-k213334 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K213334, Monarch Platform, Urology, by Auris Health, Inc. https://foiadocs.com/products/510k-submission-records-k173156 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173156, Integrated CardioRespiratory System, by Sensydia, Inc. https://foiadocs.com/products/records-fda-510k-submission-k172959 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K172959, PeraServer and PeraTrend, by Perahealth, Inc. https://foiadocs.com/products/510k-submission-documents-k955650 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K955650, OLYMPUS SD SERIES SNARES, by Olympus America, Inc. https://foiadocs.com/products/510k-documentation-cangaroo-rm-antibacterial-envelope-k233991-elutia-inc 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K233991, CanGaroo RM Antibacterial Envelope, by Elutia, Inc. https://foiadocs.com/products/full-510k-record-i-stat-chem8-epoc-blood-analysis-systems-k191360 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191360, i-STAT CHEM8+ cartridge with the i-STAT 1 System, by Abbott Point of Care, Inc. https://foiadocs.com/products/fda-phytolon-two-color-petition-submission-documents-cap-4c0326-docket-no-fda-2024-c-1085-cap-4c0332-docket-no-fda-2024-c-3229 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-510k-k920977-meritranstm-disposable-transducer 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K920977, MERITRANS(TM) DISPOSABLE TRANSDUCER, by Merit Medical Systems, Inc. https://foiadocs.com/products/fda-510k-k222579-belun-sleep-system-bls-100 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K222579, Belun Sleep System BLS-100, by Belun Technology Company Limited https://foiadocs.com/products/fda-510k-k982408-aerotee-model-1001 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K982408, AEROTEE, MODEL # 1001, by Piper Medical Products https://foiadocs.com/products/fda-510k-k101532-nessi-otc-spacer 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K101532, NESSI OTC SPACER, by Pharmacaribe https://foiadocs.com/products/fda-510k-k230545-inessa-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K230545, Inessa System, by Triple Jump Israel , Ltd. https://foiadocs.com/products/fda-510k-k191747-fujifilm-duodenoscope-model-ed-580xt 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191747, FUJIFILM Duodenoscope Model ED-580XT, by Fujifilm Corporation https://foiadocs.com/products/fda-510k-k214016-15l-cycler-drainage-bag 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K214016, 15L Cycler Drainage Bag, by Baxter Healthcare Corporation https://foiadocs.com/products/fda-510k-k222547-electric-nasal-aspirator 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K222547, Electric nasal aspirator, by Shenzhen Xinlianfeng Technology Co.,Ltd https://foiadocs.com/products/fda-510k-k080228-oralief-otc-toothpaste-for-sensitive-teeth 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080228, ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH, by Novamin Technology, Inc. https://foiadocs.com/products/fda-510k-k895513-perry-sv-1-hyperbaric-ventilator 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K895513, PERRY SV-1 HYPERBARIC VENTILATOR, by Perry Baromedical Services https://foiadocs.com/products/fda-510k-k974868-sigma-plus-monoplace-hyperbaric-chamber 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K974868, SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER, by Perry Baromedical Corp. https://foiadocs.com/products/fda-510k-k072427-sigma-series-hyperbaric-chamber 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K072427, SIGMA SERIES HYPERBARIC CHAMBER, by Perry Baromedical Corp. https://foiadocs.com/products/fda-510k-k904834-intavent-laryngeal-mask 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K904834, INTAVENT LARYNGEAL MASK, by Intavent Intl. S.A. https://foiadocs.com/products/fda-510k-k010204-stryker-navigation-system-knee-module 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K010204, STRYKER NAVIGATION SYSTEM-KNEE MODULE, by Stryker Corp. https://foiadocs.com/products/fda-510k-k130304-lma-family-of-airways 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130304, LMA FAMILY OF AIRWAYS, by The Laryngeal Mask Co., Ltd. https://foiadocs.com/products/fda-510k-k130498-osteoselect-demineralized-bone-matrix-putty 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130498, OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY, by Bacterin International, Inc. https://foiadocs.com/products/fda-510k-k131222-ampcare-esp-therapy-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131222, AMPCARE ESP THERAPY SYSTEM, by Ampcare, LLC https://foiadocs.com/products/fda-510k-k133335-powerport-implantable-port 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133335, POWERPORT IMPLANTABLE PORT, by C.R. Bard, Inc. https://foiadocs.com/products/fda-510k-k142364-barrx-rfa-self-sizing-balloon-catheter 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142364, Barrx RFA Self Sizing Balloon Catheter, by Covidien, LLC https://foiadocs.com/products/fda-510k-k151790-pmt-platinum-depthalon-depth-electrode 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151790, PMT Platinum Depthalon Depth Electrode, by Pmt Corporation https://foiadocs.com/products/fda-510k-k163109-oxyheal-4000-multiplace-hyperbaric-chamber-family 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K163109, OxyHeal 4000 Multiplace Hyperbaric Chamber Family, by Oxyheal Medical Systems, Inc. https://foiadocs.com/products/fda-510k-k182887-masimo-rad-67-pulse-co-oximeter-and-accessories 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182887, Masimo Rad-67 Pulse CO-Oximeter and Accessories, by Masimo Corporation https://foiadocs.com/products/fda-510k-k203028-fujifilm-distal-end-cap 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203028, FUJIFILM Distal End Cap, by Fujifilm Corporation https://foiadocs.com/products/fda-510k-k210710-pentax-medical-video-duedenoscope-ed34-i10t2 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K210710, PENTAX Medical Video Duedenoscope ED34-i10T2, by Pentax of America, Inc. https://foiadocs.com/products/fda-510k-k211585-bodyport-cardiac-scale 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K211585, Bodyport Cardiac Scale, by Bodyport, Inc. https://foiadocs.com/products/fda-510k-k211654-penumbra-system-reperfusion-catheter-red-72 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K211654, Penumbra System (Reperfusion Catheter RED 72), by Penumbra, Inc. https://foiadocs.com/products/fda-510k-k213836-intracept-intraosseous-nerve-ablation-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K213836, Intracept Intraosseous Nerve Ablation System, by Relievant Medsystems, Inc. https://foiadocs.com/products/fda-fcn-002035-chemistry-and-toxicology-review-memos-and-correspondence 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-510k-k993953-oves-cervical-cap 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K993953, OVES CERVICAL CAP, by Veos , Ltd. https://foiadocs.com/products/fda-510k-k042145-ready-heat-blanket 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042145, READY-HEAT BLANKET, by Techtrade, LLC https://foiadocs.com/products/fda-510k-pre-market-application-k191402-includes-all-associated-agency-communications-class-2-recall-z-1498-2020-and-requests-for-additional-information 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191402, Heater-Cooler System 3T, by Livanova Deutschland, GmbH https://foiadocs.com/products/fda-510k-k223144-submission-full-application-and-pertinent-data-for-noah-medical-corp-s-galaxy-system 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K223144, Galaxy System, by Noah Medical Corp. https://foiadocs.com/products/fda-510k-k110374-submission-full-file-including-master-file-submissions-responses-and-review-memos 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110374, MAX PULSE SYSTEM, by Medicore Co., Ltd. https://foiadocs.com/products/fda-510k-k172431-submission-full-file-including-master-file-submissions-responses-and-review-memos 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K172431, Cardiovascular Analzyer, by Physiowave, Inc. https://foiadocs.com/products/fda-510k-k002837 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K002837, BIS ENGINE, by Aspect Medical Systems, Inc. https://foiadocs.com/products/fda-510k-k912061 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K912061, HEPARIN ADSORBENT, by Sigma Diagnostics, Inc. https://foiadocs.com/products/fda-510k-k221623 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K221623, FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm, by Gme German Medical Engineering GmbH https://foiadocs.com/products/fda-510k-k023083 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K023083, SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800, by Mettler Electronics Corp. https://foiadocs.com/products/fda-510k-contents-ovulon-monitor-k973860 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K973860, OVULON MONITOR, by Conception Technology, Inc. https://foiadocs.com/products/fda-internal-memoranda-for-color-additive-petitions-spirulina-extract 2026-08-09T23:20:43-05:00 daily https://foiadocs.com/products/fda-510k-k153302-coflex-if-cleared-09-08-2016 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153302, coflex-IF, by Paradigm Spine, LLC https://foiadocs.com/products/fda-510k-k220872-saberscope5-laparoscope-redacted-application 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K220872, Saberscope5 Laparoscope, by Xenocor, Inc. https://foiadocs.com/products/fda-510k-k211411-penumbra-system-red-68-reperfusion-catheter-full-submission 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K211411, Penumbra System (RED 68 Reperfusion Catheter), by Penumbra, Inc. https://foiadocs.com/products/fda-510k-k223882-narrowband-uv-phototherapy-lamp-by-shenzhen-honpal 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K223882, Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02), by Shenzhen Honpal Optoelectronic Technology Co., Ltd. https://foiadocs.com/products/fda-510k-k232149-submission-package-and-related-communications 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K232149, BowTie™ SI Joint Fusion System, by Sail Fusion, LLC https://foiadocs.com/products/fda-510k-k203517-and-k211733-full-submissions-for-deephealth-and-lunit 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203517, Saige-Q, by DeepHealth, Inc. https://foiadocs.com/products/fda-510k-k230372-vitreject-full-submission-copy-request 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K230372, VitreJect Syringe, by Ocuject, LLC https://foiadocs.com/products/fda-510k-k232686-corvista-system-full-submission-by-corvista-health 2026-08-09T23:20:43-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K232686, CorVista® System, by Corvista Health, Inc.