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https://foiadocs.com/products/510k-submission-records-k173156 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k920977-meritranstm-disposable-transducer 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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-k092586-male-latex-condom-straight-side-or-contoured-or-flared-in-shape-either-textured-or-non-textured-lubricated-or-non-lu 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k080228-oralief-otc-toothpaste-for-sensitive-teeth 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily 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S.A. https://foiadocs.com/products/fda-510k-k010204-stryker-navigation-system-knee-module 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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. 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https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k153302-coflex-if-cleared-09-08-2016 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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 2026-08-09T20:17:56-05:00 daily https://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. https://foiadocs.com/products/fda-510k-k233590-overjet-charting-assist-submission-records 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K233590, Overjet Charting Assist, by Overjet, Inc. https://foiadocs.com/products/fda-510k-k241071-nextdent-jet-denture-base-and-teeth-submission 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K241071, NextDent Jet Denture Base; NextDent Jet Denture Teeth, by Vertex-Dental B.V. https://foiadocs.com/products/fda-510k-k233253-submission-records-request 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K233253, eCARTv5 Clinical Deterioration Suite (“eCART”), by Agilemd, Inc. https://foiadocs.com/products/fda-510k-k160127-icodeconnect-submission-by-3b-medical-inc 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160127, iCodeConnect, by 3B Medical, Inc. https://foiadocs.com/products/fda-510k-k200299-full-submission-for-curos-jet-disinfecting-cap 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200299, Curos Jet Disinfecting Cap, by 3M Company https://foiadocs.com/products/fda-510k-k221249-submission-for-lip-1f-trios-5-by-3shape 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K221249, L1P-1F (TRIOS 5), by 3Shape TRIOS A/S https://foiadocs.com/products/fda-decision-memo-and-letters-for-510k-k173352 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173352, Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever), by Concentric Medical, Inc. https://foiadocs.com/products/fda-certified-se-clearance-letter-for-510k-k041059 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K041059, EPI-MAX, by Dermagenics, Inc. https://foiadocs.com/products/fda-510k-k191461-cutaneous-tissue-adhesive-with-mesh 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191461, Exofin Fusion Skin Closure System, by Chemence Medical, Inc. https://foiadocs.com/products/fda-510k-k203714-nuvasive-thoracolumbar-interbody-systems 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203714, NuVasive Thoracolumbar Interbody Systems (Multiple Models), by Nu Vasive, Incorporated https://foiadocs.com/products/fda-510k-k903056-bacttrap 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K903056, BACTTRAP, by Pharma Systems, Inc. https://foiadocs.com/products/fda-510k-k100133-airstrip-remote-patient-monitoring-rpm-remote-data-viewing-software-version-3-1 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100133, AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1, by Airstrip Technologies, LP https://foiadocs.com/products/fda-fcn-2308 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k884685-rocket-fetal-blood-sampling-tray 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K884685, ROCKET FETAL BLOOD SAMPLING TRAY, by A & A Medical, Inc. https://foiadocs.com/products/fda-510k-k891388-1570-fetal-blood-sampling-kit 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K891388, 1570 - FETAL BLOOD SAMPLING KIT, by Transidyne General Corp. https://foiadocs.com/products/fda-510k-k831459-fetal-blood-sampling-kit-1560 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K831459, FETAL BLOOD SAMPLING KIT #1560, by Transidyne General Corp. https://foiadocs.com/products/fda-510k-k810028-fetal-blood-sampling-kit-model-1560 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K810028, FETAL BLOOD SAMPLING KIT MODEL 1560, by Transidyne General Corp. https://foiadocs.com/products/fda-510k-k232295-laa-exclusion-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K232295, LAA Exclusion System, by Syntheon, LLC https://foiadocs.com/products/fda-510k-k210293-atriclip-laa-exclusion-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K210293, AtriClip LAA Exclusion System, by AtriCure, Inc. https://foiadocs.com/products/fda-510k-k220305-syntheon-laa-exclusion-system-syntheon-laa-selection-guide 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K220305, Syntheon LAA Exclusion System, Syntheon LAA Selection Guide, by Syntheon https://foiadocs.com/products/fda-510k-k161686-f-p-infosmart 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161686, F&P InfoSmart, by Fisher & Paykel Healthcare, Ltd. https://foiadocs.com/products/fda-510k-k051843-copeland-eas-humeral-resurfacing-heads 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K051843, COPELAND EAS HUMERAL RESURFACING HEADS, by Biomet, Inc. https://foiadocs.com/products/fda-510k-k203343-wesper-lab 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203343, Wesper Lab, by Wesper, Inc. https://foiadocs.com/products/fda-510k-k200718-arthrosurface-wristmotion-total-wrist-arthroplasty-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200718, Arthrosurface WristMotion Total Wrist Arthroplasty System, by Arthrosurface, Inc. https://foiadocs.com/products/fda-510k-k191525-kinematx-total-wrist-arthroplasty-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191525, KinematX Total Wrist Arthroplasty System, by Extremity Medical, LLC https://foiadocs.com/products/fda-510k-k132250-integra-freedom-wrist-arthroplasty-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132250, INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM, by Integra LifeSciences Corporation https://foiadocs.com/products/fda-510k-k021859-wrist-implant 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K021859, WRIST IMPLANT, by Avanta Orthopaedics, Inc. https://foiadocs.com/products/fda-510k-k030474-ph-buffering-plastic-applicator-tampon 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K030474, PH BUFFERING PLASTIC APPLICATOR TAMPON, by Rostam , Ltd. https://foiadocs.com/products/fda-510k-k200567-asi-plethysmogrpah-analyzer 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200567, ASI Plethysmogrpah Analyzer, by Arterial Stiffness, Inc. https://foiadocs.com/products/fda-510k-k072187-pioneer-lowtop-spinal-rod-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K072187, PIONEER LOWTOP SPINAL ROD SYSTEM, by Pioneer Surgical Technology https://foiadocs.com/products/fda-510k-k233737-ulricheasyinject-max-2m-xd-10140-ulricheasyinject-max-3-xd-10150-ulricheasyinject-max-3-xd-10180 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k191394-illumisite-platform 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191394, ILLUMISITE Platform, by Covidien, LLC https://foiadocs.com/products/fda-510k-k003458-soft-beat-fetal-heart-rate-electrode-model-sbt-7000 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K003458, SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000, by Clinical Innovations, Inc. https://foiadocs.com/products/fda-510k-k141194-fm-3000-fetal-monitor 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141194, FM-3000 FETAL MONITOR, by Advanced Instrumentations, Inc. https://foiadocs.com/products/fda-510k-k030691-fetal-spiral-electrode-model-fse07000 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K030691, FETAL SPIRAL ELECTRODE, MODEL FSE07000, by Clinical Innovations, Inc. https://foiadocs.com/products/fda-510k-k041163-isopure-complete-water-system-for-hemodialysis-md-400-and-md-600-series 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K041163, ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES, by Isopure, Corp. https://foiadocs.com/products/fda-510k-k223479-aquabase-nx 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K223479, AQUAbase nX, by B.Braun Medical, Inc. https://foiadocs.com/products/fda-510k-k213507-aquaa 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K213507, AquaA, by Fresenius Medical Care Rental Therapies Group, LLC https://foiadocs.com/products/fda-510k-k133783-ameriwater-centurion-1500-reverse-osmosis-system-with-heat-sanitization 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133783, AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, by Ameriwater https://foiadocs.com/products/fda-510k-k131904-mediqa-single-pass-reverse-osmosis-system-with-heat-sanitization-mediqa-double-pass-reverse-osmosis-system-with-heat-sa 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k142285-ameriwater-heatsan-3-phase-208v-60hz-ameriwater-heatsan-3-phase-460v-60hz-ameriwater-heatsan-3-phase-575v-60hz 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k143617-aquac-uno-h 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143617, AquaC UNO H, by Vivonic GmbH https://foiadocs.com/products/fda-510k-k161844-matrix-pre-treatment-controller 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161844, Matrix Pre-Treatment Controller, by Better Water, LLC https://foiadocs.com/products/fda-510k-k151637-upt-series-medical-ro-water-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151637, UPT Series Medical RO Water System, by Specialty Water Technologies https://foiadocs.com/products/fda-510k-k220290-revitalair-430 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K220290, Revitalair 430+, by Us Hyperbaric Network https://foiadocs.com/products/fda-510k-k222625-shield-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K222625, Shield System, by Radiaction , Ltd. https://foiadocs.com/products/fda-510k-k202365-pentax-medical-video-duodenoscope-ed32-i10 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K202365, Pentax Medical Video Duodenoscope ED32-i10, by Pentax of America, Inc. https://foiadocs.com/products/fda-510k-k203162-advanix-biliary-stent-with-naviflex-rx-delivery-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203162, Advanix Biliary Stent with NaviFlex RX Delivery System, by Boston Scientific Corporation https://foiadocs.com/products/fda-510k-k212748-disposable-dual-action-tissue-clip 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K212748, Disposable Dual Action Tissue Clip, by Micro-Tech (Nanjing) Co., Ltd. https://foiadocs.com/products/fda-510k-k221124-mantis-clip 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K221124, MANTIS Clip, by Boston Scientific Corporation https://foiadocs.com/products/fda-510k-k233705 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K233705, CellFX Percutaneous Electrode System (SYS3000), by Pulse Biosciences, Inc. https://foiadocs.com/products/fda-approval-routing-summary-for-anda-213680-biocon 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/approval-routing-summary-for-anda-213719-zydus 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k120446-fujinon-fujifilm-ultrasonic-endoscope-eg-530ur2-and-eg-530ut2 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120446, FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2, by Fujinon, Inc. https://foiadocs.com/products/fda-510k-k121599-crit-line-clip-clic 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121599, CRIT-LINE CLIP (CLIC), by Fresenius Medical Care-North America https://foiadocs.com/products/fda-510k-k132987-cobra-fundus-camera 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132987, COBRA FUNDUS CAMERA, by C.S.O. S.R.L. https://foiadocs.com/products/fda-510k-k133393-gelpoint-path-transanal-access-platform 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133393, GELPOINT PATH TRANSANAL ACCESS PLATFORM, by Applied Medical Resources Corp. https://foiadocs.com/products/fda-510k-k141281-crit-line-clip-clic-blood-chamber 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141281, CRIT-LINE CLIP (CLIC) BLOOD CHAMBER, by Fresenius Medical Care Renal Therapies Group, LLC https://foiadocs.com/products/fda-510k-k150108-reverse-medical-micro-vascular-plug-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150108, Reverse Medical Micro Vascular Plug System, by Reverse Medical Corporation https://foiadocs.com/products/fda-510k-k150402-endoluminal-occlusion-system-eos 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150402, Endoluminal Occlusion System-EOS, by Artventive Medical Group, Inc. https://foiadocs.com/products/fda-510k-k913228-interpore-imz-cylinder-implant-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K913228, INTERPORE IMZ CYLINDER IMPLANT SYSTEM, by Interpore Intl. https://foiadocs.com/products/fda-510k-k935958-crit-line-blood-chamber-with-e-beam 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K935958, CRIT-LINE BLOOD CHAMBER WITH E-BEAM, by In-Line Diagnostics Corp. https://foiadocs.com/products/fda-510k-k952434-endopore-dental-implant-abutments 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K952434, ENDOPORE DENTAL IMPLANT ABUTMENTS, by Innova Corp. https://foiadocs.com/products/fda-510k-k980987-becton-dickinson-syringe 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K980987, BECTON DICKINSON SYRINGE, by Bd Becton Dickinson Vacutainer Systems Preanalytic https://foiadocs.com/products/fda-510k-k153778-nester-embolization-coils-tornado-embolization-coils 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153778, Nester Embolization Coils, Tornado Embolization Coils, by Cook Incorporated https://foiadocs.com/products/fda-510k-k170984-lg-beauty-led-mask 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K170984, LG BEAUTY LED MASK, by Lg Electronics https://foiadocs.com/products/fda-510k-k855032-imz-intramobile-cylinder-implant 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K855032, IMZ INTRAMOBILE CYLINDER IMPLANT, by Interpore Intl. https://foiadocs.com/products/fda-510k-k071669-integra-selector-ultrasonic-surgical-aspirator-system-with-bone-tip 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K071669, INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP, by Integra Radionics, Inc. https://foiadocs.com/products/fda-510k-k082438-bio-seal-lung-biopsy-tract-plug-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082438, Bio-Seal Lung Biopsy Tract Plug System, by AngioTech https://foiadocs.com/products/fda-510k-k091299-spectranetics-turbo-tandem-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K091299, SPECTRANETICS TURBO-TANDEM SYSTEM, by Spectranetics Corp. https://foiadocs.com/products/fda-510k-k091952-acta-vessel-occlusion-system-vos 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K091952, ACTA VESSEL OCCLUSION SYSTEM (VOS), by Nfocus Neuromedical, Inc. https://foiadocs.com/products/fda-510k-k092035-bicon-implants-with-a-2-5mm-internal-connection 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092035, BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION, by Bicon, LLC https://foiadocs.com/products/fda-510k-k140665-genprime-snap-top-split-key-cup 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140665, GenPrime Snap-Top Split Key Cup, by Genprime, Inc. https://foiadocs.com/products/fda-510k-k760243-gloves-sterile-latex-surgeons 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K760243, GLOVES, STERILE LATEX SURGEON'S, by Travenol Laboratories, S.A. https://foiadocs.com/products/fda-510k-k122118-hakim-programmable-and-precision-valve-shunt-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122118, HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM, by Codman & Shurtleff, Inc. https://foiadocs.com/products/fda-510k-k832448-triflex-surgeons-gloves 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K832448, TRIFLEX SURGEON'S GLOVES, by Travenol Laboratories, S.A. https://foiadocs.com/products/fda-den-170022-quantx 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k132691-abl90-flex 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132691, ABL90 FLEX, by Radiometer Medical Aps https://foiadocs.com/products/fda-pma-p130022-s038 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k810864-water-pik-oral-hygiene-center 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K810864, WATER PIK ORAL HYGIENE CENTER, by Teledyne, Inc. https://foiadocs.com/products/fda-510k-k895259-pik-pocketr-model-pp-3 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K895259, PIK POCKET(R), MODEL PP-3, by Teledyne Water Pik https://foiadocs.com/products/fda-510k-k950178-pharma-plast-purelinetm-comforttm-amp-clini-sofs-plus-subcutaneous-infusion-set 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K950178, PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET, by Pharma-Plast Intl. A/S https://foiadocs.com/products/fda-510k-k181006-bb-613-watch-oximeter 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K181006, BB-613 Watch Oximeter, by Bio-Beat Technologies , Ltd. https://foiadocs.com/products/fda-510k-k863131-pik-pocket-irrigating-tip 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K863131, PIK POCKET (IRRIGATING TIP), by Teledyne, Inc. https://foiadocs.com/products/fda-510k-k023046-sst-saliva-supporting-tablets 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K023046, SST SALIVA SUPPORTING TABLETS, by Sinclair Pharmaceuticals, Ltd. https://foiadocs.com/products/fda-510k-k800448-water-pik-traveler-model-79 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K800448, WATER PIK TRAVELER, MODEL 79, by Teledyne, Inc. https://foiadocs.com/products/fda-de-novo-den130045-heartflow-ffrct-v1-4 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k180943-biowavego 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K180943, BioWaveGO, by Biowave Corporation https://foiadocs.com/products/fda-510k-k990177-nellcor-puritan-bennett-achieva-ventilator-and-report-generator 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K990177, NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR, by Nellcor Puritan Bennett, Inc. https://foiadocs.com/products/fda-p960031-periogard-periodontal-tissue-monitor 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k960749-hemochron-jr-microcoagulation-low-range-act 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K960749, HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT, by International Technidyne Corp. https://foiadocs.com/products/fda-510k-k941007-catalog-no-j-act-qc-act 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K941007, CATALOG NO. J-ACT+ & QC-ACT+, by International Technidyne Corp. https://foiadocs.com/products/fda-510k-k014008-hemochron-jr-citrate-aptt-cuvette 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K014008, HEMOCHRON JR. CITRATE APTT CUVETTE, by Itc, Inc. https://foiadocs.com/products/fda-510k-k190969-endoscope-reprocessor-oer-elite 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190969, ENDOSCOPE REPROCESSOR OER-Elite, by Olympus Medical Systems Corp. https://foiadocs.com/products/fda-510k-k192020-indicator-physical-chemical-sterilization-process 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k190297-indicator-biological-sterilization-process 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190297, Celerity HP Incubator, by STERIS Corporation https://foiadocs.com/products/fda-510k-k183294-indicator-biological-sterilization-process 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K183294, CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack, by STERIS Corporation https://foiadocs.com/products/fda-nda-019084-nizoral-ketoconazole-cream-2-labeling-and-package-insert 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k210497-seaspine-spacer-system-nm-hollywood-hollywood-vi-pacifica-redondo-ventura-vu-a-pod-l-nanometalene-seaspine 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k091736-sharpsmart-disposable-sharps-container-model-s2 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K091736, SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2, by Daniels Corporation Pty, Inc. https://foiadocs.com/products/fda-510k-k190929-xvision-spine-system-xvs 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190929, xvision Spine system (XVS), by Augmedics, Ltd. https://foiadocs.com/products/fda-510k-k100434-clave-neutron 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100434, CLAVE NEUTRON, by Icu Medical, Inc. https://foiadocs.com/products/fda-510k-k100442-fastclamp-endoscopic-clamping-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100442, FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM, by Surgical Innovations Group Plc https://foiadocs.com/products/fda-510k-k110569-audicor-cpam-cardiopulmonary-ambulatory-monitor 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110569, AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR), by Inovise Medical, Inc. https://foiadocs.com/products/fda-510k-k131686-inomax-dsir-delivery-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131686, INOMAX DSIR (DELIVERY SYSTEM), by Ino Therapeutics/Ikaria https://foiadocs.com/products/fda-510k-k140796-medusa-vascular-plug 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140796, MEDUSA VASCULAR PLUG,, by Endoshape, Inc. https://foiadocs.com/products/fda-510k-k141313-reverse-medical-micro-vascular-plug-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141313, REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM, by Reverse Medical Corporation https://foiadocs.com/products/fda-510k-k143213-inomax-dsir-plus-mri 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143213, INOmax DSIR Plus MRI, by Ino Therapeutics/Ikaria https://foiadocs.com/products/fda-510k-k150313-ablation-confirmation 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150313, Ablation Confirmation, by Neuwave Medical, Inc. https://foiadocs.com/products/fda-510k-k760488-airway-dual-channel 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K760488, AIRWAY, DUAL CHANNEL, by Hudson Oxygen Therapy Sales Co. https://foiadocs.com/products/fda-510k-k844550-hobbs-medical-jayco-aspiration-catheter 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K844550, HOBBS MEDICAL/JAYCO ASPIRATION CATHETER, by Hobbs Medical, Inc. https://foiadocs.com/products/fda-510k-k882967-bone-fixation-wire 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K882967, BONE FIXATION WIRE, by Baxter Healthcare Corp https://foiadocs.com/products/fda-510k-k142754-surearly-pregnancy-test-strip-surearly-digital-pregnancy-test 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142754, Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test, by Sugentech, Inc. https://foiadocs.com/products/fda-510k-k152768-assure-tech-hcg-pregnancy-serum-urine-combo-test-cassette-assure-tech-hcg-pregnancy-serum-urine-combo-test-strip 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k093065-finesse-personal-insulin-delivery-patch-model-fg-2000 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093065, FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000, by Calibra Medical, Inc. https://foiadocs.com/products/fda-510k-k132792-ecoship-disposable-sharps-container-ecoship-disposable-sharps-container 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132792, ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER, by Daniels Sharpsmart, Inc. https://foiadocs.com/products/fda-510k-k110277-rapidpoint-405-neonatal-bilirubin 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110277, RAPIDPOINT 405 NEONATAL BILIRUBIN, by Siemens Healthcare Diagnostics https://foiadocs.com/products/fda-510k-k081151-compumedics-neuvo 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K081151, COMPUMEDICS NEUVO, by Compumedics USA, Ltd. https://foiadocs.com/products/fda-510k-k050833-lectrode-junction-box-model-je-921a 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K050833, ELECTRODE JUNCTION BOX, MODEL JE-921A, by Nihon Kohden America, Inc. https://foiadocs.com/products/fda-510k-k042384-europort-recording-microelectrode-array-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042384, NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM, by Cyberkinetics, Inc. (Cki) https://foiadocs.com/products/fda-510k-k073491-eeg-1100a-switch-box 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K073491, EEG-1100A SWITCH BOX, by Nihon Kohden America, Inc. https://foiadocs.com/products/fda-510k-k211034-corvus-radiation-therapy-planning-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K211034, Corvus Radiation Therapy Planning System, by Best Nomos https://foiadocs.com/products/fda-510k-k123769-zx-i-power-add-on 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123769, ZX-I POWER ADD ON, by Spinergy, Inc. https://foiadocs.com/products/fda-510k-k171401-elitech-clinical-systems-bilirubin-total-4-1-elitech-clinical-systems-bilirubin-direct-4-1 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171401, ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1, by Elitechgroup https://foiadocs.com/products/pma-160017-medtronic-minimed-insulin-pump-systems-minimed-670g-amp-780g 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k150408-v-steady-v-fast 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150408, V-STEADY, V-FAST, by G21, S.R.L. https://foiadocs.com/products/fda-510k-k180995-vscan-extend 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K180995, Vscan Extend, by GE Medical Systems Ultrasound and Primary Care Diagnostics https://foiadocs.com/products/fda-510k-k244027-sansa-hsat 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K244027, SANSA HSAT, by Huxley Medical https://foiadocs.com/products/fda-bla-125057-supplement-s-400-humira-approved-on-october-17-2016 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-food-contact-notification-fcn-1933-isononanoic-acid-esters-with-dipentaerythritol 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k053379 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K053379, RELI-ON ONE STEP, ORTHODONTIC ADHESIVE, by Classone Orthodontics, Inc. https://foiadocs.com/products/fda-510k-k080445 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080445, LION SE ONE STEP ORTHODONTIC ADHESIVE, by Classone Orthodontics, Inc. https://foiadocs.com/products/fda-510k-k221052 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K221052, Self-Fitting hearing aids, by Huizhou Jinghao Medical Technology Co., Ltd. https://foiadocs.com/products/fda-510k-k240011 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K240011, Lymphedema Compression, by Jkh Health Co., Ltd. https://foiadocs.com/products/fda-510k-k240867 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K240867, cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems, by Roche Molecular Systems, Inc. https://foiadocs.com/products/fda-510k-k241108 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K241108, RemedyLogic AI MRI Lumbar Spine Reader, by Remedy Logic, Inc. https://foiadocs.com/products/fda-510k-k242086 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K242086, MagDI System (MAG-01, DS-01), by Gt Metabolic Solutions, Inc. https://foiadocs.com/products/fda-510k-k242604 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K242604, Helios+ UV-C System, by Preventamed Technologies, Inc. Dba Surfacide Manufacturing https://foiadocs.com/products/fda-510k-k243213 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K243213, Self-Forming Magnet (FLEX SFM), by GI Windows, Inc. https://foiadocs.com/products/fda-510k-k243750 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K243750, SimpleStitch Suturing System, by Envision Endoscopy https://foiadocs.com/products/fda-510k-k162393 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K162393, The ViewRay (MRIdian) Linac System, by Viewray, Incorporated https://foiadocs.com/products/fda-510k-k180513 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K180513, CustomizedBone Service, by Fin-Ceramica Faenza S.P.A. https://foiadocs.com/products/fda-510k-k201867 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k071545 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K071545, Z-800 VOLUMETRIC INFUSION PUMP, by Zyno Medical, LLC https://foiadocs.com/products/fda-510k-k100705 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100705, ZYNO Z-800 INFUSION SYSTEM MODEL Z-800, by Zyno Medical, LLC https://foiadocs.com/products/fda-510k-k120685 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120685, ZYNO MEDICAL ADMINISTRATION SET, by Zyno Medical, LLC https://foiadocs.com/products/fda-510k-k130690 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130690, Z-800 INFUSION SYSTEM, by Zyno Medical, LLC https://foiadocs.com/products/fda-510k-k202839 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K202839, Overlapped Compression Therapy, by Jkh Health Co., Ltd. https://foiadocs.com/products/fda-510k-k220075 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K220075, Spartan Center Wire, by Spartan Micro, Inc. https://foiadocs.com/products/fda-510k-k000471 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K000471, FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT, by Future Diagnostics B.V. https://foiadocs.com/products/fda-510k-k032716 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K032716, PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE), by Portex , Ltd. https://foiadocs.com/products/fda-510k-k032958 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K032958, PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000, by United Medical Systems, Inc. https://foiadocs.com/products/fda-510k-k131817 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131817, EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, by Osmunda Medical Device Consulting Co., Ltd. https://foiadocs.com/products/fda-510k-k143094 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143094, QuantaFlo, by Semler Scientific, Inc. https://foiadocs.com/products/fda-510k-k152055 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152055, Ceramax Skin Barrier Cream, by Oculus Innovative Sciences https://foiadocs.com/products/fda-510k-k192579 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192579, X-Guide Surgical Navigation System, by X-Nav Technologies, LLC https://foiadocs.com/products/fda-510k-k200662 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200662, X-Guide® Surgical Navigation System, by X-Nav Technologies, LLC https://foiadocs.com/products/fda-510k-k210365 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K210365, Second Opinion, by Pearl, Inc. https://foiadocs.com/products/fda-510k-k210971 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K210971, EnteraLoc Flow, by Vonco Products https://foiadocs.com/products/fda-510k-k771228 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K771228, LIFECARE EMPTY CONTAINER, by Abbott Laboratories https://foiadocs.com/products/fda-510k-k791774 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K791774, LIFE CARE 1000ML.EMP. 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Y-TRAN, by Abbott Laboratories https://foiadocs.com/products/fda-510k-k844077 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K844077, NUTRIMIX EMPTY CONTAINER, by Abbott Laboratories https://foiadocs.com/products/fda-510k-k875076 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K875076, FLORIDA PROBE, by Florida Probe Corp. https://foiadocs.com/products/fda-510k-k903058 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K903058, BACT-HME (TM), by Pharma Systems, Inc. https://foiadocs.com/products/fda-510k-k920501 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K920501, SILCLAMPS DEGANIA SILICONE, by Puritas Health Care, Inc. https://foiadocs.com/products/fda-510k-k991972 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K991972, INFANT FLOW SYSTEM, by Sensor Medics Corp. https://foiadocs.com/products/fda-510k-k100341 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100341, SPERMCHECK FERTILITY, by Princeton BioMeditech Corp. https://foiadocs.com/products/fda-510k-k004028 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K004028, ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING, by Maersk Medical, Ltd. https://foiadocs.com/products/fda-510k-k040047 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K040047, POLYGRAFT BGS; BONE GRAFT SUBSTITUTE, by Osteobiologics, Inc. https://foiadocs.com/products/fda-510k-k042075 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042075, QUILL SYNTHETIC ABSORBABLE BARBED SUTURE, by Quill Medical, Inc. https://foiadocs.com/products/fda-510k-k051656 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K051656, OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM, by Osteobiologics, Inc. https://foiadocs.com/products/fda-510k-k081440 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K081440, BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES, by Smiths Medical Asd, Inc. https://foiadocs.com/products/fda-510k-k083124 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K083124, NIM 3.0, by Medtronic Xomed, Inc. https://foiadocs.com/products/fda-510k-k093027 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093027, STRAUMANN RC TEMPORARY ABUTMENTS, by Straumann USA https://foiadocs.com/products/fda-510k-k112686 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K112686, NEXT GEN EMG ENDOTRACHEAL TUBE, by Medtronic Xomed, Inc. https://foiadocs.com/products/fda-510k-k141558 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141558, QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, by Surgical Specialties Corp https://foiadocs.com/products/fda-510k-k143659 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143659, Equinoxe Mega Prosthesis, by Exactech, Inc. https://foiadocs.com/products/fda-510k-k152223 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k161307 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161307, NICO Myriad, by Nico Corporation https://foiadocs.com/products/fda-510k-k170826 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K170826, Perfadex Plus, by Xvivo Perfusion AB https://foiadocs.com/products/fda-510k-k180499 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K180499, Reprocessed LigaSure Maryland Jaw Sealer/Divider, by Stryker Sustainability Solutions https://foiadocs.com/products/fda-510k-k181420 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K181420, Aequalis Flex Revive Shoulder System, by Tornier, Inc. https://foiadocs.com/products/fda-510k-k182588 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182588, Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider, by Surgical Instrument Service and Savings Inc.(Dba Medline Ren https://foiadocs.com/products/fda-510k-k183067 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K183067, Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System, by Taiwan Aulisa Medical Devices Technologies, Inc. https://foiadocs.com/products/fda-510k-k190043 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190043, Halley resin, by Dentsply Sirona https://foiadocs.com/products/fda-510k-k191332 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191332, XACT Robotic System, by Xact Robotics, Ltd. https://foiadocs.com/products/fda-510k-k192930 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192930, Dymaxeon Spine System, by Back 2 Basics Direct, LLC https://foiadocs.com/products/fda-510k-k203626 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203626, SureStrip Vitrification Straw, SureLock Vitrification Straw, by Allwin Medical Devices, Inc. https://foiadocs.com/products/fda-510k-k203768 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203768, Omnipod 5 ACE Pump (Pod), by Insulet Corporation https://foiadocs.com/products/fda-510k-k210136 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K210136, PhantomMSK Hip, by OrthoGrid Systems, Inc. https://foiadocs.com/products/fda-510k-k230013 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K230013, Silk'n Titan Allways, by Silk'N Beauty , Ltd. https://foiadocs.com/products/fda-510k-k230251 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K230251, Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A), by Stryker Sustainability Solutions https://foiadocs.com/products/fda-510k-k232511 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K232511, Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019), by Surgical Instrument Service and Savings, Inc. https://foiadocs.com/products/fda-510k-k232644 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K232644, neuro42 MRI System, by Neuro42, Inc. https://foiadocs.com/products/fda-510k-k234055 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K234055, DEKA Loop, by Deka Research and Development https://foiadocs.com/products/fda-510k-k240044 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K240044, CADDIE, by Odin Medical Limited https://foiadocs.com/products/fda-510k-k240285 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K240285, Huxley SANSA Home Sleep Apnea Test (1000-00), by Huxley Medical https://foiadocs.com/products/fda-510k-k240376 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K240376, Electroporation System (N3000), by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. https://foiadocs.com/products/fda-510k-k240597 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K240597, TERA HARZ CLEAR, by Graphy, Inc. https://foiadocs.com/products/fda-510k-k241168 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K241168, System 83 Revolve Endoscope Washer/Disinfector, by Wassenburg Medical, Inc. https://foiadocs.com/products/fda-510k-k241488 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K241488, TrainFES Advance, by Trainfes https://foiadocs.com/products/fda-510k-k241872 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K241872, Remanufactured EndoWrist ProGrasp Forceps (420093), by Rebotix https://foiadocs.com/products/fda-510k-k242382 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K242382, décoLITE LED Device, by iSMART Developments, Ltd. https://foiadocs.com/products/fda-510k-k243442 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K243442, iBOT® PMD, by Mobius Mobility https://foiadocs.com/products/fda-510k-k894614 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K894614, BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE, by Bivona Medical Technologies https://foiadocs.com/products/fda-510k-k962175 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K962175, PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE, by Smiths Industries Medical Systems, Inc. https://foiadocs.com/products/fda-510k-k000655 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K000655, PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE, by Ahava Stein https://foiadocs.com/products/fda-510k-k002028 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K002028, BRAVO PH MONITORING SYSTEM, by Endonetics, Inc. https://foiadocs.com/products/fda-510k-k002456 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K002456, MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992, by Becton Dickinson Vacutainer Systems https://foiadocs.com/products/fda-510k-k004006 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K004006, SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER, by Lumenis, Inc. https://foiadocs.com/products/fda-510k-k021550 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K021550, LUMENIS SELECTA DUET, by Ellex Medical Pty, Ltd. https://foiadocs.com/products/fda-510k-k022357 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K022357, TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815, by Boston Scientific, Target https://foiadocs.com/products/fda-510k-k023706 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K023706, ULTROID HEMORRHOID MANAGEMENT SYSTEM, by Ultroid, LLC https://foiadocs.com/products/fda-510k-k030315 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K030315, MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM, by Ultroid, LLC https://foiadocs.com/products/fda-510k-k031099 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K031099, SORB+HISORB+CARTRIDGE, by Renal Solutions, Inc. https://foiadocs.com/products/fda-510k-k031649 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K031649, SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES, by Fink Engineering Pty, Ltd. https://foiadocs.com/products/fda-510k-k031891 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K031891, VIRTUOSAPH, by Terumo Cardiovascular Systems Corp. https://foiadocs.com/products/fda-510k-k031949 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K031949, TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75, by Baylis Medical Co., Inc. https://foiadocs.com/products/fda-510k-k050753 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K050753, STRYKER DISCMONITOR, by Stryker Instruments https://foiadocs.com/products/fda-510k-k051587 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K051587, TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470, by Tracoe Medical GmbH https://foiadocs.com/products/fda-510k-k073693 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K073693, COSTORSOL, by Preservation Solutions, Inc. https://foiadocs.com/products/fda-510k-k082455 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082455, RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER, by Gulf Coast Hyperbarics, Inc. https://foiadocs.com/products/fda-510k-k083453 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K083453, COSTORSOL, by Preservation Solutions, Inc. https://foiadocs.com/products/fda-510k-k093297 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093297, EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE, by Epocal, Inc. https://foiadocs.com/products/fda-510k-k093362 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093362, 2008 HEMODIALYSIS SORBENT SYSTEM, by Renal Solutions, Inc. https://foiadocs.com/products/fda-510k-k100261 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100261, PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD, by Tei Biosciences, Inc. https://foiadocs.com/products/fda-510k-k100662 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100662, FEMVUE CORNUAL BALLOON CATHETER, by Femasys, Inc. https://foiadocs.com/products/fda-510k-k101847 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K101847, URGENT PC STIMULATOR; URGENT PC LEAD SET, by Uroplasty, Inc. https://foiadocs.com/products/fda-510k-k102912 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K102912, INTERLOCK FIBERED IDC OCCLUSION SYSTEM, by Boston Scientific https://foiadocs.com/products/fda-510k-k123835 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123835, 2008 HEMODIALYSIS SORBENT SYSTEM, by Renal Solutions, Inc. https://foiadocs.com/products/fda-510k-k130113 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130113, PICCOLO LACTATE TEST SYSTEM, by Abaxis, Inc. https://foiadocs.com/products/fda-510k-k131908 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131908, 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC), by Fresenius Medical Care Renal Therapies Group, LLC https://foiadocs.com/products/fda-510k-k132561 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132561, NURO NEUROMODULATION SYSTEM, by Advanced Uro-Solutions, Inc. https://foiadocs.com/products/fda-510k-k132578 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132578, INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM, by Boston Scientific Corp https://foiadocs.com/products/fda-510k-k140667 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140667, WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER, by Well Lead Medical Co., Ltd. https://foiadocs.com/products/fda-510k-k142567 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142567, RETeval Visual Electrodiagnostic Device, by Lkc Technologies, Inc. https://foiadocs.com/products/fda-510k-k143179 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143179, The LINK® Endo-Model® Knee System, by Waldemar Link GmbH & Co. KG https://foiadocs.com/products/fda-510k-k150538 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150538, Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider, by Stryker Sustainability Solutions https://foiadocs.com/products/fda-510k-k151208 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151208, Powder Free Nitrile Examination Glove, by Vrg Khai Hoan Joint Stock Company https://foiadocs.com/products/fda-510k-k152077 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152077, MaxiGen, by Hans Biomed Corp. https://foiadocs.com/products/fda-510k-k153745 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153745, Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider, by Surgical Instrument Service and Savings Inc.(Dba Medline Ren https://foiadocs.com/products/fda-510k-k162751 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K162751, Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider, by Surgical Instrument Services and Savings, Inc. https://foiadocs.com/products/fda-510k-k163512 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K163512, Zio AT ECG Monitoring System, by iRhythm Technologies, Inc. https://foiadocs.com/products/fda-510k-k171886 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171886, OverStitch SX Endoscopic Suturing System (ESS), by Apollo Endosurgery, Inc. https://foiadocs.com/products/fda-510k-k172856 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K172856, Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider, by Stryker Sustainability Solutions https://foiadocs.com/products/fda-510k-k180121 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K180121, Rafugen DBM, by Cellumed Co., Ltd. https://foiadocs.com/products/fda-510k-k180346 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K180346, Byte Aligner System, by Straight Smile, LLC https://foiadocs.com/products/fda-510k-k180451 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K180451, Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider, by Stryker Sustainability Solutions https://foiadocs.com/products/fda-510k-k180479 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K180479, ReDS System, by Sensible Medical Innovations , Ltd. https://foiadocs.com/products/fda-510k-k180855 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K180855, Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System, by Kci USA, Inc. https://foiadocs.com/products/fda-510k-k181502 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K181502, Zio AT ECG Monitoring System, ZEUS System, by iRhythm Technologies, Inc. https://foiadocs.com/products/fda-510k-k181642 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K181642, B-Laser Atherectomy System, by Eximo Medical, Ltd. https://foiadocs.com/products/fda-510k-k181980 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K181980, OsseoScrew System, by Alphatec Spine, Inc. https://foiadocs.com/products/fda-510k-k182078 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182078, MiniCollect K2E K2EDTA Tubes, by Greiner Bio-One Na, Inc. https://foiadocs.com/products/fda-510k-k182971 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182971, SpaceOAR Vue Hydrogel, by Augmenix, Inc. https://foiadocs.com/products/fda-510k-k190269 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190269, PureLift, by Xtreem Pulse, LLC https://foiadocs.com/products/fda-510k-k191057 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191057, Park's Pectus System, by Tdm Co., Ltd. https://foiadocs.com/products/fda-510k-k192120 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k200107 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200107, epoc Blood Analysis System, by Epocal, Inc. https://foiadocs.com/products/fda-510k-k201631 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K201631, VersaWrap Nerve Protector, by Alafair Biosciences, Inc. https://foiadocs.com/products/fda-510k-k202327 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K202327, Invictus™ OsseoScrew® System, by Alphatec Spine, Inc. https://foiadocs.com/products/fda-510k-k203362 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203362, TRACOE vario, by Tracoe Medical GmbH https://foiadocs.com/products/fda-510k-k203634 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203634, BioPoly Great Toe Hemiarthroplasty Implant, by BioPoly, LLC https://foiadocs.com/products/fda-510k-k203689 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203689, Tidepool Loop, by Tidepool Project https://foiadocs.com/products/fda-510k-k211008 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K211008, Bose SoundControl Hearing Aids, by Bose Corporation https://foiadocs.com/products/fda-510k-k211291 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K211291, Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D, by Fiagon GmbH https://foiadocs.com/products/fda-510k-k211318 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k212237 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K212237, 3D-Cut, by 3D-Side S.A. https://foiadocs.com/products/fda-510k-k213114 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K213114, BentrioTM Allergy Blocker, by Altamira Therapeutics, Inc. https://foiadocs.com/products/fda-510k-k213398 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K213398, EMBOLD Fibered Detachable Coil System, by Boston Scientific Corporation https://foiadocs.com/products/fda-510k-k213424 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K213424, Jabra Enhance Plus, by GN Hearing A/S https://foiadocs.com/products/fda-510k-k213657 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K213657, DEEPVESSEL FFR, by Keyamed Na, Inc. https://foiadocs.com/products/fda-510k-k220481 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K220481, Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019), by Stryker Sustainability Solutions https://foiadocs.com/products/fda-510k-k220628 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K220628, LINK Endo-Model EVO Knee System, by Waldemar Link GmbH & Co. KG https://foiadocs.com/products/fda-510k-k220935 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k221011 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K221011, AI.ME System, by Venus Concept USA, Inc. https://foiadocs.com/products/fda-510k-k221385 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K221385, LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02), by Ovesco Endoscopy AG https://foiadocs.com/products/fda-510k-k221743 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k222395 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K222395, Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo, by Ellex Medical Pty, Ltd. https://foiadocs.com/products/fda-510k-k223656 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K223656, AmeriWater MediQA Reverse Osmosis System (MSP3HF), by AmeriWater, LLC https://foiadocs.com/products/fda-510k-k223914 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K223914, ACTIV™ Cap, by Cleansite Medical, Inc. https://foiadocs.com/products/fda-510k-k230199 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K230199, Byte Aligner System, by Dentsply Sirona, Inc. https://foiadocs.com/products/fda-510k-k230255 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K230255, Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019, by Stryker Sustainability Solutions https://foiadocs.com/products/fda-510k-k230948 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K230948, BFlex™ 2 Slim 3.8 Single-Use Bronchoscope, by Verathon Medical (Canada) Ulc https://foiadocs.com/products/fda-510k-k231553 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K231553, OverStitch NXT Endoscopic Suturing System, by Apollo Endosurgery, Inc. https://foiadocs.com/products/fda-510k-k232730 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K232730, Aventus Thrombectomy System, by Inquis Medical https://foiadocs.com/products/fda-510k-k233199 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K233199, ROSA® Shoulder System, by Orthosoft Inc (D/B/A Zimmer Cas) https://foiadocs.com/products/fda-510k-k233700 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K233700, Avicenna Roboflex, by Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi https://foiadocs.com/products/fda-510k-k234027 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K234027, embecta Insulin Delivery System, by Embecta Medical I, LLC https://foiadocs.com/products/fda-510k-k240062 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K240062, ARVIS® Shoulder, by Insight Medical Systems, Inc. https://foiadocs.com/products/fda-510k-k240117 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K240117, Aventus Thrombectomy System (IM-2001/IM-0002), by Inquis Medical https://foiadocs.com/products/fda-510k-k240426 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K240426, Aventus Clot Management System, by Inquis Medical https://foiadocs.com/products/fda-510k-k240624 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K240624, InfuLife, by First Medical Source, LLC https://foiadocs.com/products/fda-510k-k240776 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K240776, Celsio Flexible Cryocatheter System, by Endocision Technologies, Inc. https://foiadocs.com/products/fda-510k-k241169 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K241169, Entarik NI Feeding Tube System, by Gravitas Medical, Inc. https://foiadocs.com/products/fda-510k-k241211 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K241211, CoLumbo, by Smart Soft Healthcare https://foiadocs.com/products/fda-510k-k242076 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K242076, VersaCross™ RF Wire, by Baylis Medical Company https://foiadocs.com/products/fda-510k-k242152 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K242152, SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141), by Epic Medical Pte. , Ltd. https://foiadocs.com/products/fda-510k-k242473 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k242913 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K242913, Jasmate® Toothpaste, by Jasberry Healthcare Private Limited https://foiadocs.com/products/fda-510k-k243838 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K243838, NEXXT MATRIXX® SI System, by Nexxt Spine https://foiadocs.com/products/fda-510k-k250367 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K250367, CoLumboX, by Smart Soft Healthcare AD https://foiadocs.com/products/fda-510k-k250555 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K250555, MallyaD injection pen adapter (MallyaD), by Biocorp Production https://foiadocs.com/products/fda-510k-k823176 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K823176, MONOJECT SAMPLETTE CAPILLARY SERUM SEP, by Sherwood Medical Co. https://foiadocs.com/products/fda-510k-k823836 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K823836, MONOJECT SAMPLETTE CAPILLARY BLOOD COLL, by Sherwood Medical Co. https://foiadocs.com/products/fda-510k-k833475 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K833475, CAPIJECT SYS CAPILLARY BLOOD COLLECT, by Terumo Medical Corp. https://foiadocs.com/products/fda-510k-k843608 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K843608, CAPILLARY BLOOD COLLECTION TUBE, by Medical Technomics, Ltd. https://foiadocs.com/products/fda-510k-k853152 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K853152, MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR, by Sherwood Medical Co. https://foiadocs.com/products/fda-510k-k864323 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K864323, CYTOLOGY BRUSHES, by Medical Packaging Corp. https://foiadocs.com/products/fda-510k-k885138 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K885138, CAPILLARY TUBE, BLOOD COLLECTION, by Coeur Laboratories, Inc. https://foiadocs.com/products/fda-510k-k903136 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K903136, ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER, by Arzco Medical Electronics, Inc. https://foiadocs.com/products/fda-510k-k904943 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K904943, TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE, by Arzco Medical Electronics, Inc. https://foiadocs.com/products/fda-510k-k905831 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K905831, ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH, by Arzco Medical Electronics, Inc. https://foiadocs.com/products/fda-510k-k911387 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K911387, CT SYTEC 4000, by GE Medical Systems https://foiadocs.com/products/fda-510k-k911422 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K911422, DRUG NEBULIZERS, by Intersurgical, Inc. https://foiadocs.com/products/fda-510k-k911425 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K911425, ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM, by Intersurgical, Inc. https://foiadocs.com/products/fda-510k-k924100 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K924100, OXYGEN CONCENTRATOR, by Allied Healthcare Products, Inc. https://foiadocs.com/products/fda-510k-k930200 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K930200, MULTI DOPPLEX II / FETAL DOPPLEX II, by Huntleigh Healthcare, Inc. https://foiadocs.com/products/fda-510k-k931368 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K931368, MICROTAINER BRAND TUBE WITH EDTA, by Bd Becton Dickinson Vacutainer Systems Preanalytic https://foiadocs.com/products/fda-510k-k945118 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K945118, EXPIRATORY BREATHING EXERCISER, by Dhd Diemolding Healthcare Div. https://foiadocs.com/products/fda-510k-k954255 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K954255, PHILIPS TOMOSCAN SR 8000, by Philips Medical Systems North America, Inc. https://foiadocs.com/products/fda-510k-k972969 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K972969, QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM, by Innovative Medical Technologies, Inc. https://foiadocs.com/products/fda-510k-k973865 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K973865, BIRTCHER UV LAMP, by Medfaxx, Inc. https://foiadocs.com/products/fda-510k-k981531 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K981531, SUTURE PLACEMENT DEVICE AND ACCESSORIES, by Lsi Solutions https://foiadocs.com/products/fda-510k-k982998 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K982998, GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE, by Greiner Meditech, Inc. https://foiadocs.com/products/fda-510k-k982999 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K982999, GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE, by Greiner Meditech, Inc. https://foiadocs.com/products/fda-510k-k990067 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K990067, SHEER GLYDE DAMS, by Louise C. Myers https://foiadocs.com/products/fda-510k-k992140 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K992140, PICCOLO METLYTE 7 REAGENT DISC, by Abaxis, Inc. https://foiadocs.com/products/fda-510k-k992244 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K992244, GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE, by Greiner Meditech, Inc. https://foiadocs.com/products/fda-510k-k993708 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K993708, BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG, by Biomagnetic Technologies, Inc. https://foiadocs.com/products/fda-510k-k011666 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K011666, CHILLIT, by Heatshield, Inc. https://foiadocs.com/products/fda-510k-k032688 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K032688, COLONOSIGHT MODEL 510B, by Sightline Technologies , Ltd. https://foiadocs.com/products/fda-510k-k093646 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093646, DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS, by DePuy Orthopaedics, Inc. https://foiadocs.com/products/fda-510k-k093679 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-510k-k101154 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K101154, CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L, by Airsep Corp. https://foiadocs.com/products/fda-510k-k121319 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121319, ZIO PATCH, by iRhythm Technologies, Inc. https://foiadocs.com/products/fda-510k-k122276 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122276, ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, by AtriCure, Inc. https://foiadocs.com/products/fda-510k-k150786 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150786, Rezum System, by Nxthera, Inc. https://foiadocs.com/products/fda-510k-k150930 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150930, Deployable Oxygen Generation System-Smaill (DOGS-S), by Airsep Corporation https://foiadocs.com/products/fda-510k-k160417 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160417, Rezum System, by Nxthera, Inc. https://foiadocs.com/products/fda-510k-k173248 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173248, CARDIOSKIN, by Bioserenity Sas https://foiadocs.com/products/fda-510k-k180237 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K180237, Rezum System, by Nxthera, Inc. https://foiadocs.com/products/fda-510k-k183309 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K183309, stentfix OTSC System Set, by Ovesco Endoscopy AG https://foiadocs.com/products/fda-510k-k201271 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K201271, Benchmark BMX96 Access System, by Penumbra, Inc. https://foiadocs.com/products/fda-510k-k213134 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K213134, Accu-Chek Solo micropump system with interoperable technology, by Roche Diabetes Care GmbH https://foiadocs.com/products/fda-510k-k222808 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K222808, Penumbra System (Reperfusion Catheter RED 43), by Penumbra, Inc. https://foiadocs.com/products/fda-510k-k223213 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K223213, Tandem Mobi Insulin Pump with Interoperable Technology, by Tandem Diabetes Care, Inc. https://foiadocs.com/products/fda-510k-k231620 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K231620, Nuubo Smart, by Smart Solutions Technologies SL https://foiadocs.com/products/fda-510k-k231675 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K231675, OneRF Ablation System, by Neuroone Medical Technologies Corp. https://foiadocs.com/products/fda-510k-k242610 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K242610, 8mm Monopolar Curved Scissors (470179), by Iconocare Health https://foiadocs.com/products/fda-foia-document-request 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_foia_document_request_icon_gold_v2.png?v=1782095344 FDA FOIA Database Request https://foiadocs.com/products/foia-pro 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/foia_pro_icon_f6ac21e7-0e79-4ef9-bde6-1e246b03dd16.png?v=1782095139 FOIA Pro https://foiadocs.com/products/custom-foia-request 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/custom_foia_request_icon_small_0a2e9924-d355-4670-a604-e71b67faa39b.png?v=1782095602 Custom FOIA Request https://foiadocs.com/products/anda-219115-bioequivalence-review-dexlansoprazole-delayed-release-capsules 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/fda-cap-4c0326-fda-phytolon-color-petition-submission-document-docket-no-fda-2024-c-1085 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/anda-219115-bioequivalence-review-dexlansoprazole-delayed-release-capsules-copy 2026-08-09T20:17:56-05:00 daily https://foiadocs.com/products/nda-216059-s-001-jaypirca-pirtobrutinib-fda-approval-package-cll-sll-supplemental-approval 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/FDANDA216059_S-01.png?v=1784674454 NDA 216059/S-001 — Jaypirca (pirtobrutinib) FDA Approval Package -- CLL/SLL Supplemental Approval https://foiadocs.com/products/fda-510k-k093679-atriclip-laa-exclusion-system-with-preloaded-gillinov-cosgrove-clip 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093679, AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip, by AtriCure, Inc. https://foiadocs.com/products/fda-510k-k242473-altis-aris-and-supris-sling-systems 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K242473, Altis, Aris and Supris Sling Systems, by Coloplast Corp. https://foiadocs.com/products/fda-510k-k221743-radio-frequency-plasma-surgical-systems-and-electrodes 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K221743, Radio Frequency Plasma Surgical Systems and Electrodes, by Jiangsu Bonss Medical Technology Co., Ltd. https://foiadocs.com/products/fda-510k-k220935-digital-dialysis-clinic-intelligent-dialysis-assistant-ida 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K220935, Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA), by Iren-Medical, Ltd. https://foiadocs.com/products/fda-510k-k211318-pico-7-and-pico-14-single-use-negative-pressure-wound-therapy-systems 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K211318, PICO 7 and PICO 14 Single Use Negative Pressure Wound Therapy Systems, by Smith Nephew Medical Limited https://foiadocs.com/products/fda-510k-k192120-venner-pneux-ett-endotracheal-tube-6-9-mm 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192120, Venner PneuX ETT (Endotracheal Tube), 6-9 mm, by Venner Medical (Singapore) Pte, Ltd. https://foiadocs.com/products/fda-510k-k152223-rectangular-multiplace-hyperbaric-chamber-system-with-touchscreen-control 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152223, Rectangular Multiplace Hyperbaric Chamber System with Touchscreen Control, by Oxyheal Medical Systems, Inc. https://foiadocs.com/products/fda-510k-k201867-homechoice-claria-apd-system-with-sharesource-connectivity-platform 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K201867, Homechoice Claria APD System with Sharesource Connectivity Platform, by Baxter Healthcare Corporation https://foiadocs.com/products/fda-510k-k152768-assure-tech-hcg-pregnancy-serum-urine-combo-test-cassette-and-strip 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152768, Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette and Strip, by Assure Tech. Co., Ltd. https://foiadocs.com/products/fda-510k-k210497-seaspine-spacer-interbody-and-fusion-systems-multiple-models 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K210497, SeaSpine Spacer, Interbody and Fusion Systems (Multiple Models), by SeaSpine Orthopedics Corporation https://foiadocs.com/products/fda-510k-k192020-celerity-chemical-indicators-and-verify-v24-biological-indicator-label 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192020, Celerity Chemical Indicators and VERIFY V24 Biological Indicator Label, by STERIS Corporation https://foiadocs.com/products/fda-510k-k142285-ameriwater-heatsan-3-phase-208v-460v-575v-60hz 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142285, AmeriWater Heatsan, 3-Phase (208V, 460V, 575V, 60Hz), by Ameriwater https://foiadocs.com/products/fda-510k-k131904-mediqa-single-and-double-pass-reverse-osmosis-systems-with-heat-sanitization 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131904, MEDIQA Single and Double Pass Reverse Osmosis Systems with Heat Sanitization, by Ameriwater https://foiadocs.com/products/fda-510k-k233737-ulricheasyinject-max-2m-and-max-3-xd-10140-xd-10150-xd-10180 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K233737, ulricheasyINJECT Max 2M and Max 3 (XD 10140, XD 10150, XD 10180), by Ulrich GmbH & Co. KG https://foiadocs.com/products/fda-510k-k233407-atriclip-laa-exclusion-system-family-gillinov-cosgrove-pro-v-and-flex-v 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K233407, AtriClip LAA Exclusion System Family (Gillinov-Cosgrove, PRO-V and Flex-V), by AtriCure, Inc. https://foiadocs.com/products/fda-510k-k081472-smartport-ct-vortex-lp-titanium-and-triumph-low-profile-titanium-ports 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K081472, SmartPort CT Vortex, LP Titanium and Triumph Low Profile Titanium Ports, by AngioDynamics, Inc. https://foiadocs.com/products/fda-510k-k240782-cellfx-percutaneous-electrode-system-sys3000-cpe013-cpe018 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K240782, CellFX Percutaneous Electrode System (SYS3000, CPE013, CPE018), by Pulse Biosciences, Inc. https://foiadocs.com/products/fda-510k-k092586-male-latex-condom-textured-or-non-textured-lubricated-or-non-lubricated 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092586, Male Latex Condom (Textured or Non-Textured, Lubricated or Non-Lubricated), by Innolatex (Thailand) Limited https://foiadocs.com/products/fda-510k-k223299-ambu-ascope-5-broncho-hd-5-0-2-2-ambu-ascope-5-broncho-hd-5-6-2-8-ambu-aview-2-advance 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K223299, Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance, by Ambu A/S https://foiadocs.com/products/fda-510k-k212382-ambu-ascope-gastro-ambu-abox-2 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K212382, Ambu® aScope™ Gastro, Ambu® aBox™2, by Ambu A/S https://foiadocs.com/products/fda-510k-k060734-fresenius-com-tec-automated-cell-separator-and-c5l-s5l-platelet-sets 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K060734, Fresenius COM.TEC Automated Cell Separator and C5L/S5L Platelet Sets, by Fresenius Medical Care North America https://foiadocs.com/products/fda-510k-quartex-occipito-cervico-thoracic-spinal-system-excelsiusgps-instruments-globus-medical-inc 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K231850, QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments, by Globus Medical, Inc. https://foiadocs.com/products/fda-510k-enhanced-aurora-medical-diode-system-and-related-accessories-psoria-shield-inc 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K230076, Enhanced AURORA™ Medical Diode System, and related accessories, by Psoria-Shield, Inc. https://foiadocs.com/products/fda-510k-k202459-bact-trap-pharma-mini-and-bact-hme-hme-filter-family 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K202459, Bact-Trap, Pharma Mini and Bact-HME HME/Filter Family, by Pharma System AB https://foiadocs.com/products/fda-510k-k222689-mallya-injection-pen-adapter-mallya-for-solostar 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K222689, Mallya Injection Pen Adapter (Mallya® for Solostar®), by Biocorp Production https://foiadocs.com/products/fda-510k-k231849-minicap-extended-life-pd-transfer-set-with-twist-clamp-5c4482a-5c4483 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K231849, MiniCap Extended Life PD Transfer Set with Twist Clamp (5C4482A, 5C4483), by Baxter Healthcare https://foiadocs.com/products/fda-510k-k233508-ifuse-bedrock-granite-implant-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K233508, iFuse Bedrock Granite® Implant System, by SI-BONE, Inc. https://foiadocs.com/products/fda-510k-k230645-benehold-surgical-incise-drape-with-chg-antimicrobial-ii 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K230645, BeneHold™ Surgical Incise Drape with CHG antimicrobial II, by Avery Dennison Medical , Ltd. https://foiadocs.com/products/fda-510k-k223846-ilet-ace-pump 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K223846, iLet® ACE Pump, by Beta Bionics, Inc. https://foiadocs.com/products/fda-510k-k221683-cysto-nephro-videoscope-olympus-cyf-v2-v2r-vh-vhr 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K221683, Cysto-Nephro Videoscope (Olympus CYF-V2, V2R, VH, VHR), by Olympus Medical Systems Corporation https://foiadocs.com/products/fda-510k-k222578-3m-ioban-chg-chlorhexidine-gluconate-incise-drape-contains-2-w-w-chg 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K222578, 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG), by 3M Company https://foiadocs.com/products/fda-510k-k150369-somnodent-oral-appliance-family-with-dentitrac-micro-recorder 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150369, SomnoDent Oral Appliance Family with DentiTrac Micro-recorder, by Somnomed, Inc. https://foiadocs.com/products/fda-510k-k983406-sanitherm-oral-disposable-thermometer-sheaths-for-mercury-thermometer 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K983406, Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer, by Banta Healthcare Group, Ltd. https://foiadocs.com/products/fda-510k-k001149-augustine-medical-bair-hugger-model-750-temperature-management-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K001149, Augustine Medical Bair Hugger Model 750 Temperature Management System, by Augustine Medical, Inc. https://foiadocs.com/products/fda-510k-k003335-resuscitaire-radiant-birthing-room-and-wall-mounted-warmers 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K003335, Resuscitaire Radiant, Birthing Room and Wall Mounted Warmers, by Hill-Rom Air-Shields https://foiadocs.com/products/fda-510k-k003789-speciality-56-uv-and-56-uv-toric-hefilcon-c-soft-contact-lens 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K003789, Speciality 56 UV and 56 UV Toric (Hefilcon C) Soft Contact Lens, by Specialty Ultravision, Inc. https://foiadocs.com/products/fda-510k-k020020-izzzy-tens-slim-tens-mens-tens-and-compact-tens 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K020020, Izzzy-TENS, Slim-TENS, Mens-TENS and Compact TENS, by Well-Life Healthcare, Inc. https://foiadocs.com/products/fda-510k-k030813-primary-care-solutions-prefilled-10cc-and-30cc-inflation-syringes 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K030813, Primary Care Solutions Prefilled 10cc and 30cc Inflation Syringes, by Primary Care Solutions, Inc. https://foiadocs.com/products/fda-510k-k031759-acon-spectrum-multi-drug-multi-line-drug-screen-test-card 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K031759, ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card, by ACON Laboratories, Inc. https://foiadocs.com/products/fda-510k-k041194-abbott-architect-stat-troponin-i-cardiac-marker-control-levels-l-m-and-h 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K041194, Abbott Architect STAT Troponin I Cardiac Marker Control, Levels L, M and H, by Medical Analysis Systems, Inc. https://foiadocs.com/products/fda-510k-k052607-arthrex-interference-screws-rounded-head-full-threaded-cannulated 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K052607, Arthrex Interference Screws (Rounded Head, Full Threaded, Cannulated), by Arthrex, Inc. https://foiadocs.com/products/fda-510k-k052596-modular-thumb-implant-multiple-models 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K052596, Modular Thumb Implant (Multiple Models), by Biopro, Inc. https://foiadocs.com/products/fda-510k-k061425-purewrist-scissors-dissector-and-hook-pw1101-pw1201-pw1301 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061425, PureWrist Scissors, Dissector and Hook (PW1101, PW1201, PW1301), by Cambridge Endoscopic Devices https://foiadocs.com/products/fda-510k-k062368-wako-lba-dcp-test-system-with-dcp-control-and-calibrator-sets 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062368, Wako LBA DCP Test System with DCP Control and Calibrator Sets, by Wako Chemicals USA, Inc. https://foiadocs.com/products/fda-510k-k081475-electric-drill-system-xps-4000-midas-rex-legend-ehs-ipc 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K081475, Electric Drill System (XPS 4000, Midas Rex Legend EHS, IPC), by Medtronic Xomed, Inc. https://foiadocs.com/products/fda-510k-k090413-a1cnow-professional-test-kits-10-and-20-test-and-a1cnow-self-check 2026-08-09T20:17:56-05:00 daily https://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+ Professional Test Kits (10 and 20 Test) and A1CNow Self Check, by Bayer Healthcare, LLC https://foiadocs.com/products/fda-510k-k092283-dimension-vista-immunoglobulin-igg-subclass-flex-reagent-cartridge 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092283, Dimension Vista Immunoglobulin IgG Subclass Flex Reagent Cartridge, by Siemens Healthcare Diagnostics https://foiadocs.com/products/fda-510k-k092602-freestyle-lite-and-freestyle-freedom-lite-blood-glucose-monitoring-systems 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092602, FreeStyle Lite and FreeStyle Freedom Lite Blood Glucose Monitoring Systems, by Abbott Diabetes Care, Inc. https://foiadocs.com/products/fda-510k-k101734-visionscope-high-definition-endoscopy-camera-system-with-endoscopes 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K101734, VisionScope High Definition Endoscopy Camera System with Endoscopes, by Visionscope Technologies, LLC https://foiadocs.com/products/fda-510k-k103254-peristeen-anal-irrigation-system-with-accessory-unit-and-rectal-catheter 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K103254, Peristeen Anal Irrigation System with Accessory Unit and Rectal Catheter, by Coloplast A/S https://foiadocs.com/products/fda-510k-k111904-ark-methotrexate-assay-calibrator-and-control 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K111904, ARK Methotrexate Assay, Calibrator and Control, by Ark Diagnostics, Inc. https://foiadocs.com/products/fda-510k-k112860-peristeen-anal-irrigation-system-with-accessory-unit-and-rectal-catheter 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K112860, Peristeen Anal Irrigation System with Accessory Unit and Rectal Catheter, by Coloplast A/S https://foiadocs.com/products/fda-510k-k121593-3m-attest-super-rapid-readout-steam-challenge-packs 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121593, 3M Attest Super Rapid Readout Steam Challenge Packs, by 3M Company https://foiadocs.com/products/fda-510k-k121214-access-accutni-3-reagent-and-calibrators-for-the-access-2-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121214, Access AccuTnI+3 Reagent and Calibrators for the Access 2 System, by Beckman Coulter, Inc. https://foiadocs.com/products/fda-510k-k121248-liquoguard-csf-with-tubing-sets-1500mm-2000mm-and-safety-cushion 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121248, LiquoGuard CSF with Tubing Sets (1500mm, 2000mm) and Safety Cushion, by Moller Medical GmbH https://foiadocs.com/products/fda-510k-k133499-suzhou-beinuo-surgical-staplers-circular-hemorrhoidal-and-linear 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133499, Suzhou Beinuo Surgical Staplers (Circular, Hemorrhoidal and Linear), by Suzhou Beinuo Medical Equipment Co. , Ltd. https://foiadocs.com/products/fda-510k-k133948-bard-monopty-and-max-core-disposable-core-biopsy-instruments 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133948, Bard Monopty and Max-Core Disposable Core Biopsy Instruments, by Bard Peripheral Vascular, Inc. https://foiadocs.com/products/fda-510k-k132219-straumann-variobase-abutment-nnc-rn-wn 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132219, Straumann Variobase Abutment (NNC, RN, WN), by Straumann USA, LLC https://foiadocs.com/products/fda-510k-k141114-bioplex-2200-25-oh-vitamin-d-kit-calibrator-set-and-controls 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141114, BioPlex 2200 25-OH Vitamin D Kit, Calibrator Set and Controls, by Bio-Rad Laboratories https://foiadocs.com/products/fda-510k-k143306-erbe-waterjet-model-erbejet-2-system-with-hybridapc-probe 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143306, ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe, by Erbe USA, Inc. https://foiadocs.com/products/fda-510k-k152842-wallstent-and-wallstent-rp-tracheobronchial-endoprosthesis 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152842, WallStent and WallStent RP Tracheobronchial Endoprosthesis, by Boston Scientific Corporation https://foiadocs.com/products/fda-510k-k163529-reliatect-post-op-dressing-with-chg-8x15cm-10x25cm 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K163529, ReliaTect Post-Op Dressing with CHG (8x15cm, 10x25cm), by Avery Dennison Corporation https://foiadocs.com/products/fda-510k-k162569-yes-oil-based-and-water-based-lubricants-and-vaginal-moisturizer 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K162569, YES Oil-Based and Water-Based Lubricants and Vaginal Moisturizer, by Biotech Lubricants, Ltd. https://foiadocs.com/products/fda-510k-k151462-si-technology-si-desis-screws 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151462, SI-TECHNOLOGY® SI-DESIS® SCREWS, by Si-Technology, LLC https://foiadocs.com/products/fda-510k-k231820-solosmart-injection-pen-adapter-solosmarta 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K231820, SoloSmart Injection Pen Adapter (SoloSmart®), by Biocorp Production https://foiadocs.com/products/fda-510k-k093395-olympus-gf-type-uc180-and-uct180-evis-exera-ii-gastrovideoscope 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093395, Olympus GF Type UC180 and UCT180 EVIS Exera II Gastrovideoscope, by Olympus Medical Systems Corporation https://foiadocs.com/products/fda-510k-k213815-sijoin-t3 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K213815, SiJoin®T3, by Vgi Medical, Inc. https://foiadocs.com/products/fda-510k-k212815-my3d-personalized-pelvic-reconstruction 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K212815, My3D® Personalized Pelvic Reconstruction, by Onkos Surgical https://foiadocs.com/products/fda-510k-k020608-hd-hdt-polymacon-soft-contact-lens-for-daily-wear 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K020608, HD/HDT (Polymacon) Soft Contact Lens for Daily Wear, by Poly Vue Technolgies, Inc. https://foiadocs.com/products/fda-510k-k170974-bd-facslyric-flow-cytometer-with-facsuite-software-and-multitest-assays 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K170974, BD FACSLyric Flow Cytometer with FACSuite Software and Multitest Assays, by Becton, Dickinson and Company https://foiadocs.com/products/fda-510k-k110424-dignity-mini-port-and-low-profile-port-attachable-and-pre-attached 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110424, Dignity Mini Port and Low Profile Port (Attachable and Pre-Attached), by Medcomp ( Medical Components) https://foiadocs.com/products/fda-510k-k201255-tsolution-one-total-knee-application 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K201255, TSolution® One Total Knee Application, by THINK Surgical, Inc. https://foiadocs.com/products/fda-510k-k122894-geistlich-bio-oss-bio-oss-collagen-combi-kit-collagen-and-perio-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122894, Geistlich Bio-Oss, Bio-Oss Collagen, Combi-Kit Collagen and Perio System, by Geistlich Pharma AG https://foiadocs.com/products/fda-510k-k092467-vectorvision-and-kolibri-cranial-ent-navigation-systems 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092467, VectorVision and Kolibri Cranial/ENT Navigation Systems, by Brainlab AG https://foiadocs.com/products/fda-510k-k173841-axs-catalyst-distal-access-catheter-058x115cm-058x132cm-060x132cm 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173841, AXS Catalyst Distal Access Catheter (058x115cm, 058x132cm, 060x132cm), by Stryker https://foiadocs.com/products/fda-510k-k231168-tracstar-ldp-and-zoom-88-large-distal-platforms 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K231168, TracStar LDP and Zoom 88 Large Distal Platforms, by Imperative Care, Inc. https://foiadocs.com/products/fda-510k-k991702-microtainer-brand-chemistry-tubes-with-microgard-closure 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K991702, Microtainer Brand Chemistry Tubes with Microgard Closure, by Becton Dickinson Vacutainer Systems https://foiadocs.com/products/fda-510k-k200065-cobas-liat-nucleic-acid-tests-influenza-a-b-influenza-a-b-and-rsv-strep-a 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200065, cobas Liat Nucleic Acid Tests (Influenza A/B; Influenza A/B & RSV; Strep A), by Roche Molecular Systems, Inc. https://foiadocs.com/products/fda-510k-k222839-endowrist-stapler-30-45-and-sureform-30-45-60-systems 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K222839, EndoWrist Stapler 30/45 and SureForm 30/45/60 Systems, by Intuitive Surgical, Inc. https://foiadocs.com/products/fda-510k-k142900-parietex-progrip-mesh-plug-and-patch-system-and-progrip-laparoscopic-mesh 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142900, Parietex Progrip Mesh, Plug and Patch System and Progrip Laparoscopic Mesh, by Sofradim Production https://foiadocs.com/products/fda-510k-k173796-parietex-surgical-mesh-composite-mesh-and-optimized-composite-mesh 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173796, Parietex Surgical Mesh, Composite Mesh and Optimized Composite Mesh, by Sofradim Production https://foiadocs.com/products/fda-510k-k100635-arrowgard-evolution-antimicrobial-picc-s-44041-s-45041-series 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100635, Arrowgard Evolution Antimicrobial PICC (S-44041/S-45041 Series), by Arrow Intl., Inc. https://foiadocs.com/products/fda-510k-k161642-cavux-cervical-cage 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161642, CAVUX™ Cervical Cage, by Providence Medical Technology, Inc. https://foiadocs.com/products/fda-510k-k123731-biotene-oral-balance-gel-dry-mouth-rinse-and-moisturizing-spray 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123731, Biotene Oral Balance Gel, Dry Mouth Rinse and Moisturizing Spray, by Glaxosmithkline Consumer Healthcare (Gskch) https://foiadocs.com/products/fda-510k-k101098-replens-long-lasting-vaginal-moisturizer-35g-tube-model-83035 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K101098, Replens Long-Lasting Vaginal Moisturizer (35g Tube, Model 83035), by Lil Drug Store Products, Inc. https://foiadocs.com/products/fda-510k-k160433-v-pro-1-plus-and-v-pro-max-low-temperature 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160433, V-PRO® 1 Plus and V-PRO® maX Low Temperature, by STERIS Corporation https://foiadocs.com/products/fda-510k-k183636-spyscope-ds-and-ds-ii-access-catheters-with-spyglass-ds-controller 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K183636, SpyScope DS and DS II Access Catheters with SpyGlass DS Controller, by Boston Scientific Corporation https://foiadocs.com/products/fda-510k-k140726-captivator-emr-device-for-standard-gastroscopes 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140726, Captivator EMR Device for Standard Gastroscopes, by Boston Scientific Corp https://foiadocs.com/products/fda-510k-k202769-velys-robotic-assisted-solution 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K202769, VELYS™ Robotic-Assisted Solution, by Depuy Ireland UC https://foiadocs.com/products/fda-510k-k192785-optiscanner-5000-glucose-monitoring-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192785, OptiScanner® 5000 Glucose Monitoring System, by Optiscan Biomedical Corporation https://foiadocs.com/products/fda-510k-k191713-cs-series-fp-radiographic-fluoroscopic-systems-with-ca-100s-fluoroshield 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191713, CS-Series-FP Radiographic/Fluoroscopic Systems with CA-100S FluoroShield, by Omega Medical Imaging, LLC https://foiadocs.com/products/fda-510k-k100454-hydrocoil-embolic-system-hydroframe-multiple-models 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100454, HydroCoil Embolic System - HydroFrame (Multiple Models), by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k093002-azur-peripheral-hydrocoil-endovascular-embolization-system-detachable-35 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093002, AZUR Peripheral HydroCoil Endovascular Embolization System - Detachable 35, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k162999-v-grip-and-azur-detachment-controllers-for-hydrocoil-and-microplex-coils 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K162999, V-Grip and AZUR Detachment Controllers for HydroCoil and MicroPlex Coils, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k150877-acl-top-family-50-series-350-cts-550-cts-750-750-cts-750-las 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150877, ACL TOP Family 50 Series (350 CTS, 550 CTS, 750, 750 CTS, 750 LAS), by Instrumentation Laboratory CO https://foiadocs.com/products/fda-510k-k203247-ifuse-torq-implant-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203247, iFuse-TORQ™ Implant System, by SI-BONE, Inc. https://foiadocs.com/products/fda-510k-k134031-threader-monorail-and-over-the-wire-micro-dilatation-catheters 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K134031, Threader Monorail and Over-the-Wire Micro-Dilatation Catheters, by Boston Scientific Corporation https://foiadocs.com/products/fda-510k-k072412-option-smartcare-for-evitaxl-with-capno-kit-and-capnosmart-co2-sensor 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K072412, Option SmartCare for EvitaXL with Capno Kit and CapnoSmart CO2 Sensor, by Drager Medical AG & Co. Kgaa https://foiadocs.com/products/fda-510k-k190103-v-pro-max-2-max-1-plus-and-1-low-temperature-sterilization-systems 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190103, V-PRO maX 2, maX, 1 Plus and 1 Low Temperature Sterilization Systems, by STERIS Corporation https://foiadocs.com/products/fda-510k-k093138-mt9000-series-electro-stimulator-mt9000-mt9004 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093138, MT9000 Series Electro-Stimulator (MT9000-MT9004), by Shenzhen Dongdixin Technology Co., Ltd. https://foiadocs.com/products/fda-510k-k140717-clinitek-novus-automated-urine-chemistry-analyzer 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140717, Clinitek Novus Automated Urine Chemistry Analyzer, by Siemens Healthcare Diagnostics https://foiadocs.com/products/fda-510k-k121456-aution-hybrid-au-4050-automated-urine-analyzer-with-uriflet-s-9ha-strips 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121456, Aution Hybrid AU-4050 Automated Urine Analyzer with Uriflet S 9HA Strips, by Arkray, Inc. https://foiadocs.com/products/fda-510k-k172257-truedx-and-vericlear-hcg-early-result-pregnancy-tests 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K172257, TrueDX and VeriClear hCG Early Result Pregnancy Tests, by True Diagnostics, Inc. https://foiadocs.com/products/fda-510k-k173860-s5-and-s5i-intravascular-ultrasound-and-core-guided-therapy-systems 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173860, s5 and s5i Intravascular Ultrasound and CORE Guided Therapy Systems, by Volcano Corporation https://foiadocs.com/products/fda-510k-k153642-dailies-aquacomfort-plus-toric-and-multifocal 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153642, DAILIES AquaComfort Plus, Toric and Multifocal, by Alcon Laboratories, Inc. https://foiadocs.com/products/fda-510k-k182075-benevision-n-series-patient-monitors-n1-n12-n15-n17-n19-n22 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182075, BeneVision N Series Patient Monitors (N1, N12, N15, N17, N19, N22), by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. https://foiadocs.com/products/fda-510k-k041995-gp-general-purpose-mini-pig-nephrostomy-and-biliary-drainage-catheters 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K041995, GP General Purpose, Mini-Pig, Nephrostomy and Biliary Drainage Catheters, by Uresil, LLC https://foiadocs.com/products/fda-510k-k151986-advia-centaur-testosterone-ii-tstii-and-shbg-assays-with-calibrators 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151986, ADVIA Centaur Testosterone II (TSTII) and SHBG Assays with Calibrators, by Siemens Healthcare Diagnostics, Inc. https://foiadocs.com/products/fda-510k-k092086-amerigel-wound-dressing-plus-15g-30g-90g-tubes 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092086, AmeriGel Wound Dressing Plus (15g, 30g, 90g Tubes), by Amerx Health Care Corp. https://foiadocs.com/products/fda-510k-k111372-palindrome-symmetric-tip-and-mahurkar-maxid-dual-lumen-catheters 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K111372, Palindrome Symmetric Tip and Mahurkar MaxID Dual Lumen Catheters, by Covidien https://foiadocs.com/products/fda-510k-k060743-ultrasafe-passive-delivery-system-tamper-evident-and-x-series 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K060743, UltraSafe Passive Delivery System (Tamper Evident and X-Series), by Safety Syringes, Inc. https://foiadocs.com/products/fda-510k-k143462-anscare-chitoclot-gauze-prescription-and-over-the-counter 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143462, AnsCare ChitoClot Gauze (Prescription and Over-the-Counter), by Benq Materials Corporation https://foiadocs.com/products/fda-510k-k161210-rialto-si-fusion-system-with-ipc-powerease-and-stealthstation-instruments 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161210, Rialto SI Fusion System with IPC Powerease and StealthStation Instruments, by Medtronic Sofamor Danek https://foiadocs.com/products/fda-510k-k101298-endochoice-grasping-insulated-alligator-jaw-and-rat-tooth-forceps 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K101298, EndoChoice Grasping Insulated Alligator Jaw and Rat Tooth Forceps, by Endochoice, Inc. https://foiadocs.com/products/fda-510k-k153479-nvisionvle-imaging-console-marking-probes-14-17-20mm-and-inflation-system 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153479, NvisionVLE Imaging Console, Marking Probes (14/17/20mm) and Inflation System, by Ninepoint Medical, Inc. https://foiadocs.com/products/fda-510k-k150504-gus-astra-tee-and-astra-vr-probe-reprocessors 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150504, GUS ASTRA TEE and ASTRA VR Probe Reprocessors, by Pci Medical, Inc. https://foiadocs.com/products/fda-510k-k103110-mini-trek-and-trek-rx-otw-coronary-dilatation-catheters 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K103110, Mini Trek and Trek RX/OTW Coronary Dilatation Catheters, by Abbott Vascular-Cardiac Therapies https://foiadocs.com/products/fda-510k-k122797-enseal-g2-articulating-tissue-sealers-straight-and-curved-jaw 2026-08-09T20:17:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122797, Enseal G2 Articulating Tissue Sealers (Straight and Curved Jaw), by Ethicon Endo-Surgery, LLC