https://foiadocs.com/ daily https://foiadocs.com/products/1002-fda-approval-bla-125062-674 2026-08-09T23:19:55-05:00 daily https://foiadocs.com/products/fda-510k-k133338-ligasure-5-mm-maryland-jaw-sealer-divider-one-step-sealing-lf-17xx 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133338, LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX), by Covidien, Formerly Valleylab, A Division of Tyco H https://foiadocs.com/products/fda-510k-k123215-viscostat-clear 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123215, VISCOSTAT CLEAR, by Ultradent Products, Inc. https://foiadocs.com/products/fda-510k-k130738-endoscopic-linear-cutting-staplers-with-single-use-loading-units 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130738, ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS, by Nanjing Maidixin Medical Device Co., Ltd. https://foiadocs.com/products/fda-510k-k103477-permobil-m300-m400 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K103477, PERMOBIL M300 / M400, by Permobil AB https://foiadocs.com/products/fda-510k-k141389-sapphire-infusion-pump 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141389, SAPPHIRE INFUSION PUMP, by Q Core Medical , Ltd. https://foiadocs.com/products/fda-510k-k142024-brightmatter-navigation-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142024, BRIGHTMATTER NAVIGATION SYSTEM, by Synaptive Medical, Inc. https://foiadocs.com/products/fda-510k-k131973-unexef-38g-ultrasound-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131973, UNEXEF-38G ULTRASOUND SYSTEM, by Toyota Tsusho Corporation https://foiadocs.com/products/fda-510k-k140575-engstrom-carestation-engstrom-pro 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140575, ENGSTROM CARESTATION, ENGSTROM PRO, by Datex-Ohmeda, Inc. https://foiadocs.com/products/fda-510k-k142973-resolution-clip 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142973, Resolution Clip, by Boston Scientific Corporation https://foiadocs.com/products/fda-510k-k141399-freedom-spinal-cord-stimulator-scs-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141399, FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM, by Stimwave Technologies Incorporated https://foiadocs.com/products/fda-510k-k010315-iscreen-vision-screener 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K010315, ISCREEN VISION SCREENER, by Iscreen, LLC https://foiadocs.com/products/fda-510k-k133237-gel-bead-embolization-spheres 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133237, GEL-BEAD EMBOLIZATION SPHERES, by Vascular Solutions, Inc. https://foiadocs.com/products/fda-510k-k141288-voyant-electrosurgical-generator-voyant-5mm-laparoscopic-sealer-divider-device 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141288, VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE, by Applied Medical Resources https://foiadocs.com/products/fda-510k-k112174-ncb-periprosthetic-femur-polyaxial-locking-plate-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K112174, NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM, by Zimmer, Inc. https://foiadocs.com/products/fda-510k-k132733-orthohelix-syndesmosis-fixation-devices 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132733, ORTHOHELIX SYNDESMOSIS FIXATION DEVICES, by Orthohelix Surgical Designs, Inc. https://foiadocs.com/products/fda-510k-k141929-accu-chek-connect-diabetes-management-app 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141929, ACCU-CHEK CONNECT DIABETES MANAGEMENT APP, by Roche Diagnostics Corporation https://foiadocs.com/products/fda-510k-k132403-annextm-adjacent-level-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132403, ANNEXTM ADJACENT LEVEL SYSTEM, by Spine Wave, Inc. https://foiadocs.com/products/fda-510k-k050418-tissue-fixation-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K050418, TISSUE FIXATION SYSTEM, by Tfs Manufacturing Pty, Ltd. https://foiadocs.com/products/fda-510k-k141081-filtek-bulk-fill-posterior-restroative 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141081, FILTEK BULK FILL POSTERIOR RESTROATIVE, by 3M Espe Dental Products https://foiadocs.com/products/fda-510k-k113088-hummingbird-subdural-h900ds-drainage-and-icp-hummingbird-subdural-h800s-icp-only 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K113088, HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY), by Innerspace, Inc. https://foiadocs.com/products/fda-510k-k131198-tipi-otc 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131198, TIPI OTC, by Contipi , Ltd. https://foiadocs.com/products/fda-510k-k142327-smartrack-feeding-tube-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142327, smARTrack Feeding Tube System, by Art Healthcare , Ltd. https://foiadocs.com/products/fda-510k-k130921-alivecor-heart-monitor-otc 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130921, ALIVECOR HEART MONITOR OTC, by AliveCor, Inc. https://foiadocs.com/products/fda-510k-k143275-iolmaster700 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143275, IOLMaster700, by Carl Zeiss Meditec, Inc. https://foiadocs.com/products/fda-510k-k141518-nellcor-bedside-respiratory-patient-monitoring-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141518, Nellcor Bedside Respiratory Patient Monitoring System, by Covidien https://foiadocs.com/products/fda-510k-k143700-cpap-cannulaide 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143700, CPAP Cannulaide, by Salter Labs https://foiadocs.com/products/fda-510k-k141943-breathe-technologies-life2000-ventilation-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141943, BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM, by Breathe Technologies https://foiadocs.com/products/fda-510k-k150638-af541-se-full-face-mask 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150638, AF541 SE Full Face Mask, by Respironics, Inc. https://foiadocs.com/products/fda-510k-k150572-respire-pink-series-herbst-ef 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150572, Respire Pink Series-Herbst-EF, by Respire Medical Holding https://foiadocs.com/products/fda-510k-k100116-lasertouchone-otc 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100116, LASERTOUCHONE (OTC), by Laser Health Technologies, LLC https://foiadocs.com/products/fda-510k-k140497-ecvue-mapping-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140497, ECVUE MAPPING SYSTEM, by Cardioinsight Technologies, Inc. https://foiadocs.com/products/fda-510k-k151623-penumbra-system-110-aspiration-tubing 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151623, Penumbra System 110 Aspiration Tubing, by Penumbra, Inc. https://foiadocs.com/products/fda-510k-k160449-penumbra-system-penumbra-pump-max 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160449, Penumbra System, Penumbra Pump MAX, by Penumbra, Inc. https://foiadocs.com/products/fda-510k-k161640-penumbra-system-ace-68-reperfusion-catheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161640, Penumbra System ACE 68 Reperfusion Catheter, by Penumbra, Inc. https://foiadocs.com/products/fda-510k-k981973-safe-t-fill-capillary-blood-collection-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K981973, SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM, by Ram Scientific https://foiadocs.com/products/fda-510k-k141745-iqqa-bodyimaging-software 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141745, IQQA-BODYIMAGING SOFTWARE, by Edda Technology https://foiadocs.com/products/fda-510k-k151436-pico-single-use-negative-pressure-wound-therapy-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151436, PICO Single Use Negative Pressure Wound Therapy System, by Smith & Nephew Medical, Ltd. https://foiadocs.com/products/fda-510k-k042515-smith-nephew-inc-high-performance-knee 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042515, SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE, by Smith & Nephew, Inc. https://foiadocs.com/products/fda-510k-k140828-neuroreader-medical-image-processing-software 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140828, NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE, by Brainreader Aps https://foiadocs.com/products/fda-510k-k863547-medtronic-model-5455-disposable-surgical-cable 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K863547, MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE, by Medtronic Vascular https://foiadocs.com/products/fda-510k-k803311-ll100-cryosurgical-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K803311, LL100 CRYOSURGICAL SYSTEM, by Wallach Surgical Devices, Inc. https://foiadocs.com/products/fda-510k-k152033-cook-ecm-powder 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152033, Cook ECM Powder, by Cook Biotech Incorporated https://foiadocs.com/products/fda-510k-k150409-vivace-electrosurgical-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150409, VIVACE Electrosurgical System, by Sung Hwan E&B Co.,Ltd https://foiadocs.com/products/fda-510k-k152525-tr-band-radial-compression-device 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152525, TR BAND Radial Compression Device, by Terumo Medical Corporation https://foiadocs.com/products/fda-510k-k082185-ge-logiq-e9-diagnostic-ultrasound-system-models-5205000-5205000-2 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082185, GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2, by Ge Medical Systems Ultrasound and Primary Care Dia https://foiadocs.com/products/fda-510k-k110943-logiq-e9 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110943, LOGIQ E9, by GE Healthcare https://foiadocs.com/products/fda-510k-k092271-ge-logiq-e9-bt2010-diagnostic-ultrasound-system-model-5205000-3-5205000-4 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092271, GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4, by GE Healthcare https://foiadocs.com/products/fda-510k-k141757-alere-i-strep-a 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141757, ALERE I STREP A, by Alere Scarborough, Inc. https://foiadocs.com/products/fda-510k-k120151-nebulae-i 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120151, NEBULAE I, by Northgate Technologies, Inc. https://foiadocs.com/products/fda-510k-k120640-insuflow-synergy-port 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120640, INSUFLOW SYNERGY PORT, by Lexion Medical, LLC https://foiadocs.com/products/fda-510k-k063367-45l-core-insufflator-model-f114 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K063367, 45L CORE INSUFFLATOR, MODEL F114, by W.O.M. World of Medicine AG https://foiadocs.com/products/fda-510k-k041502-thrombelastograph-teg-platelet-mapping-assay 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K041502, THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY, by Haemoscope Corp. https://foiadocs.com/products/fda-510k-k150041-cora-coagulation-resonance-analysis-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150041, CORA (Coagulation Resonance Analysis) System, by Coramed Technologies, LLC https://foiadocs.com/products/fda-510k-k140279-s9-greenhills 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140279, S9 GREENHILLS, by Resmed, Ltd. https://foiadocs.com/products/fda-510k-k121173-chord-x-eptfe-suture 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121173, CHORD-X EPTFE SUTURE, by On-Xlifetechnologies https://foiadocs.com/products/fda-510k-k974521-vnus-closure-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K974521, VNUS CLOSURE SYSTEM, by Vnus Medical Technologies, Inc. https://foiadocs.com/products/fda-510k-k982816-vnus-closure-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K982816, VNUS CLOSURE SYSTEM, by Vnus Medical Technologies, Inc. https://foiadocs.com/products/fda-510k-k061373-vnus-closurefast-catheter-models-cf7-7-60-and-cf7-7-100 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061373, VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100, by Vnus Medical Technologies, Inc. https://foiadocs.com/products/fda-510k-k141410-oragene-dx-ogd-500-001 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141410, ORAGENE DX OGD-500.001, by DNA Genotek, Inc. https://foiadocs.com/products/fda-510k-k152437-biowavehome-neuromodulation-pain-therapy-device 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152437, BiowaveHOME Neuromodulation Pain Therapy Device, by Biowave Corporation https://foiadocs.com/products/fda-510k-k121741-4-web-cervical-sts-spinal-truss-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121741, 4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM), by 4-Web, Inc. https://foiadocs.com/products/fda-510k-k112316-4-web-alif-spinal-truss-system-sts 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K112316, 4-WEB ALIF SPINAL TRUSS SYSTEM (STS), by 4-Web, Inc. https://foiadocs.com/products/fda-510k-k112423-collagen-tendon-sheet 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K112423, COLLAGEN TENDON SHEET, by Rotation Medical, Inc. https://foiadocs.com/products/fda-510k-k122481-lipiview-ocular-surface-interferometer 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122481, LIPIVIEW OCULAR SURFACE INTERFEROMETER, by Tearscience, Inc. https://foiadocs.com/products/fda-510k-k810701-exmoor-aural-grommet 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K810701, EXMOOR AURAL GROMMET, by Exmoor Plastics , Ltd. https://foiadocs.com/products/fda-510k-k830228-otological-ventilation-tubes-various 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K830228, OTOLOGICAL VENTILATION TUBES-VARIOUS, by Micromedics, Inc. https://foiadocs.com/products/fda-510k-k091703-hd-guide-catheter-model-90019-90022-90023-90120-90121-90130-90131 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K091703, HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131, by Concentric Medical, Inc. https://foiadocs.com/products/fda-510k-k133849-vantera-clinical-analyzer 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133849, VANTERA CLINICAL ANALYZER, by Liposcience https://foiadocs.com/products/fda-510k-k113830-vantera-clinical-analyzer 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K113830, VANTERA CLINICAL ANALYZER, by Liposcience https://foiadocs.com/products/fda-510k-k111516-nmr-lipoprofile-r-test-and-nmr-profiler 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K111516, NMR LIPOPROFILE (R) TEST AND NMR PROFILER, by Liposcience, Inc. https://foiadocs.com/products/fda-510k-k132447-vitalconnect-platform-by-vital-connect-inc 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132447, VITALCONNECT PLATFORM BY VITAL CONNECT INC., by Vitalconnect, Inc. https://foiadocs.com/products/fda-510k-k150682-cusa-excel 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150682, CUSA Excel+, by Integra Lifesciences Corp. https://foiadocs.com/products/fda-510k-k140133-infuset-flow-control-extension-set 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140133, INFUSET FLOW CONTROL EXTENSION SET, by Emed Technologies Corporation https://foiadocs.com/products/fda-510k-k141953-endoskeleton-ta-ibd-and-vbr-to-and-tt-tas-tc-tl 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141953, ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL, by Titan Spine, LLC https://foiadocs.com/products/fda-510k-k140516-terumo-pen-injector-needle-34 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140516, Terumo Pen Injector Needle 34, by Kofu Factory of Terumo Corp. https://foiadocs.com/products/fda-510k-k140149-epx-4440hd-digital-video-processor 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140149, EPX-4440HD DIGITAL VIDEO PROCESSOR, by Fujifilm Medical Systems U.S.A, Inc. https://foiadocs.com/products/fda-510k-k092780-inf-4160-plus-model-d-fj31f 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092780, INF 4160 PLUS, MODEL D-FJ31F, by Fuji Dynamics Limited https://foiadocs.com/products/fda-510k-k132071-bioactive-bone-graft-putty 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132071, BIOACTIVE BONE GRAFT PUTTY, by Biostructures, LLC https://foiadocs.com/products/fda-510k-k013721-synthetic-polysioprene-ultrasound-transducer-cover 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K013721, SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER, by CIVCO Medical Instruments Co., Inc. https://foiadocs.com/products/fda-510k-k131528-non-pyrogenic-ultrasound-transducer-cover 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131528, NON-PYROGENIC ULTRASOUND TRANSDUCER COVER, by CIVCO Medical Instruments Co., Inc. https://foiadocs.com/products/fda-510k-k051188-grafton-dbm 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K051188, GRAFTON DBM, by Osteotech, Inc. https://foiadocs.com/products/fda-510k-k012634-reprocessed-external-fixation-device 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K012634, REPROCESSED EXTERNAL FIXATION DEVICE, by Alliance Medical, Inc. https://foiadocs.com/products/fda-510k-k011034-synthes-usa-medium-external-fixation-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K011034, SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM, by Synthes (Usa) https://foiadocs.com/products/fda-510k-k152473-cas-one-ir 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152473, CAS-One IR, by Cascination AG https://foiadocs.com/products/fda-510k-k152319-auris-robotic-endoscopy-system-ares 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152319, Auris Robotic Endoscopy System (ARES), by Auris Surgical Robotics, Inc. https://foiadocs.com/products/fda-510k-k160526-masimo-o3-regional-oximeter-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160526, Masimo O3 Regional Oximeter System, by Masimo Corporation https://foiadocs.com/products/fda-510k-k151321-d-100-hba1c-d-100-hba1c-calibrator-pack 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151321, D-100 HbA1c, D-100 HbA1c Calibrator Pack, by Bio-Rad Laboratories, Inc. https://foiadocs.com/products/fda-510k-k061232-acryderm-silver-antimicrobial-thin-film-model-2006 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061232, ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006, by Acrymed, Inc. https://foiadocs.com/products/fda-510k-k160064-mome-kardia-wireless-ambulatory-ecg-monitoring-and-detection-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160064, MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System, by Infobionic, Inc. https://foiadocs.com/products/fda-510k-k133821-emprint-ablation-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133821, EMPRINT ABLATION SYSTEM, by Covidien, LLC https://foiadocs.com/products/fda-510k-k160729-elecys-brahms-pct-elecys-brahms-pct-calcheck-5 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160729, Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5, by Roche Diagnostics https://foiadocs.com/products/fda-510k-k152556-oragene-dx 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152556, Oragene Dx, by DNA Genotek, Inc. https://foiadocs.com/products/fda-510k-k141163-sterizone-sterilizer 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141163, STERIZONE STERILIZER, by Tso3, Inc. https://foiadocs.com/products/fda-510k-k152384-digital-electrocardiograph 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152384, Digital Electrocardiograph, by Shenzhen Biocare Bio-Medical Equipment Co., Ltd. https://foiadocs.com/products/fda-510k-k120084-endoscopic-retrieval-device 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120084, ENDOSCOPIC RETRIEVAL DEVICE, by United States Endoscopy Group, Inc. https://foiadocs.com/products/fda-510k-k152802-grasping-forceps 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152802, Grasping Forceps, by Micro-Tech (Nanjing) Co., Ltd. https://foiadocs.com/products/fda-510k-k153753-teliocad-multi 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153753, TelioCAD Multi, by Ivoclar Vivadent, Inc. https://foiadocs.com/products/fda-510k-k161421-single-use-surgical-suction-irrigator 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161421, Single Use Surgical Suction Irrigator, by Jiangsu Haize Medical Scientific Development Co., Ltd. https://foiadocs.com/products/fda-510k-k160403-smartstart-air-water-and-suction-valves 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160403, SmartStart Air/Water and Suction Valves, by Endochoice, Inc. https://foiadocs.com/products/fda-510k-k153249-pulpdent-solo-flowable-composite-with-mcp 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153249, Pulpdent Solo Flowable Composite with MCP, by Pulpdent Corporation https://foiadocs.com/products/fda-510k-k151816-tlc-2000-therapeutic-medical-laser-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151816, TLC-2000 Therapeutic Medical Laser System, by Theralase, Inc. https://foiadocs.com/products/fda-510k-k152139-vital-connect-platform-healthpatch-md-vitalpatch 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152139, Vital Connect Platform, HealthPatch MD, VitalPatch, by Vitalconnect, Inc. https://foiadocs.com/products/fda-510k-k153309-bd-vacutainer-ultratouch-push-button-blood-collection-set 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153309, BD Vacutainer UltraTouch Push Button Blood Collection Set, by Becton, Dickinson and Company https://foiadocs.com/products/fda-510k-k151789-locator-f-tx-attachment-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151789, LOCATOR F-Tx Attachment System, by Zest Anchors, LLC https://foiadocs.com/products/fda-510k-k150692-axios-stent-with-electrocautery-enhanced-delivery-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150692, AXIOS Stent with Electrocautery Enhanced Delivery System, by Boston Scientific Corp https://foiadocs.com/products/fda-510k-k152572-axios-stent-and-delivery-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152572, AXIOS Stent and Delivery System, by Boston Scientific Corporation https://foiadocs.com/products/fda-510k-k072076-cytoplast-ptfe-suture 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K072076, CYTOPLAST PTFE SUTURE, by Osteogenics Biomedical, Inc. https://foiadocs.com/products/fda-510k-k113610-ana-screen-with-mdss 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K113610, ANA-SCREEN WITH MDSS, by Bio-Rad Laboratories https://foiadocs.com/products/fda-510k-k151372-low-dose-ct-lung-cancer-screening-option-for-qualified-ge-systems 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151372, Low Dose CT Lung Cancer Screening Option for Qualified GE Systems, by Ge Medical Systems, LLC https://foiadocs.com/products/fda-510k-k082750-entact-septal-stapler-model-610-00100 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082750, ENTACT SEPTAL STAPLER, MODEL 610-00100, by Entrigue Surgical, Inc. https://foiadocs.com/products/fda-510k-k092178-axsos-stryker-locked-plating-system-line-extension-of-cable-plugs 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092178, AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS, by Howmedica Osteonics Corp. https://foiadocs.com/products/fda-510k-k120772-ncb-periprosthetic-trochanter-plates-and-screws-ncb-cable-button-for-ncb-oplyaxial-locking-plate 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120772, NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE, by Zimmer GmbH https://foiadocs.com/products/fda-510k-k091799-cable-ready-cable-grip-system-cable-button 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K091799, CABLE READY CABLE GRIP SYSTEM CABLE BUTTON, by Zimmer, Inc. https://foiadocs.com/products/fda-510k-k152568-c-vbr 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152568, C-VBR, by Cardinal Spine, LLC https://foiadocs.com/products/fda-510k-k132841-zyno-medical-administration-set 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132841, ZYNO MEDICAL ADMINISTRATION SET, by Zyno Medical, LLC https://foiadocs.com/products/fda-510k-k093460-coaguchek-xs-pro-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093460, COAGUCHEK XS PRO SYSTEM, by Roche Diagnostics https://foiadocs.com/products/fda-510k-k110212-inratio2-pi-nr-monitoring-system-inratio-pt-inr-test-strip 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110212, INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP, by Alere San Diego, Inc (Formally Biosite Incorporate https://foiadocs.com/products/fda-510k-k102973-silver-dental-arrest 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K102973, SILVER DENTAL ARREST, by Cooley Consulting, Inc. https://foiadocs.com/products/fda-510k-k160172-laparoscope-lens-shield-device 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160172, Laparoscope Lens Shield Device, by Medeon Biodesign, Inc. https://foiadocs.com/products/fda-510k-k160420-speqt 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160420, SpeqT, by Signostics Limited https://foiadocs.com/products/fda-510k-k141813-rhythmstar-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141813, RHYTHMSTAR SYSTEM, by RhythMedix, LLC https://foiadocs.com/products/fda-510k-k151123-pac-dent-barrier-sleeve-cover-ittm-barrier-film 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151123, Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film, by Pac-Dent International, Inc. https://foiadocs.com/products/fda-510k-k151455-3shape-abutment-designer-software 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151455, 3Shape Abutment Designer Software, by 3Shape A/S https://foiadocs.com/products/fda-510k-k031128-b-smart-model-b-01 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K031128, B-SMART, MODEL B-01, by Macosta Medical USA, LLC https://foiadocs.com/products/fda-510k-k142494-vimove 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142494, ViMove, by Dorsavi, Ltd. https://foiadocs.com/products/fda-510k-k103787-medeor-matrix 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K103787, MEDEOR MATRIX, by Kensey Nash Corp. https://foiadocs.com/products/fda-510k-k160237-cefaly 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160237, Cefaly, by Cefaly Technology https://foiadocs.com/products/fda-510k-k153549-ossix-volumax 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153549, OSSIX VOLUMAX, by Datum Dental, Ltd. https://foiadocs.com/products/fda-510k-k094041-alpha-orthopaedics-at3-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K094041, ALPHA ORTHOPAEDICS AT3 SYSTEM, by Alpha Orthopaedics https://foiadocs.com/products/fda-510k-k151964-xprecia-stride-coagulation-system-xprecia-system-pt-controls 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151964, Xprecia Stride Coagulation System, Xprecia System PT Controls, by Siemens Healthcare Diagnostics https://foiadocs.com/products/fda-510k-k143541-relieva-spinplus-balloon-sinuplasty-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143541, Relieva SpinPlus Balloon Sinuplasty System, by Acclarent, Inc. https://foiadocs.com/products/fda-510k-k150792-next-science-wound-gel 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150792, Next Science Wound Gel, by Next Science, LLC https://foiadocs.com/products/fda-510k-k152579-filmarray-respiratory-panel-ez-rp-ez 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152579, FilmArray Respiratory Panel EZ (RP EZ), by Biofire Diagnostics, LLC https://foiadocs.com/products/fda-510k-k110739-entellus-medical-sinus-guidewire 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110739, ENTELLUS MEDICAL SINUS GUIDEWIRE, by Entellus Medical, Inc. https://foiadocs.com/products/fda-510k-k141603-ultra-silver-dressings 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141603, Ultra Silver Dressings, by Milliken Healthcare Products, LLC https://foiadocs.com/products/fda-510k-k141619-luofucon-silver-foam-dressing 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141619, LUOFUCON SILVER FOAM DRESSING, by Huizhou Foryou Medical Devices Co., Ltd. https://foiadocs.com/products/fda-510k-k160752-harmonic-hd-1000i-shears-20-cm-length-harmonic-hd-1000i-shears-36-cm-length 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160752, HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length, by Ethicon Endo-Suregery, LLC https://foiadocs.com/products/fda-510k-k092849-blood-collection-tube-samples-for-use-with-point-of-care-blood-analyzer 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092849, BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER, by Epocal, Inc. https://foiadocs.com/products/fda-510k-k160429-bc-5390-auto-hematology-analyzer 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160429, BC-5390 Auto Hematology Analyzer, by Mindray Bio-Medical Electronics Co., Ltd. https://foiadocs.com/products/fda-510k-k153756-microlyte-ag 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153756, Microlyte Ag, by Imbed Biosciences, Inc. https://foiadocs.com/products/fda-510k-k160783-procellera 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160783, Procellera, by Vomaris Innovations, Inc. https://foiadocs.com/products/fda-510k-k152519-mtr550-tentative-antimicrobial-silver-wound-gel 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152519, MTR550 (Tentative) Antimicrobial Silver Wound Gel, by Medical Technology Research, Inc. https://foiadocs.com/products/fda-510k-k153049-lithovue-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153049, LithoVue System, by Boston Scientific Corporation https://foiadocs.com/products/fda-510k-k142922-spyglass-ds-direct-visualization-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142922, SpyGlass DS Direct Visualization System, by Boston Scientific Corporation https://foiadocs.com/products/fda-510k-k902319-bauer-temno-biopsy-needle 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K902319, BAUER TEMNO BIOPSY NEEDLE, by Proact, Ltd. https://foiadocs.com/products/fda-510k-k143014-f5 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143014, F5, by Permobil AB https://foiadocs.com/products/fda-510k-k050891-tox-a-b-quick-chek 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K050891, TOX A/B QUICK CHEK, by Techlab, Inc. https://foiadocs.com/products/fda-510k-k143563-infusion-aspiration-catheter-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143563, Infusion Aspiration Catheter System, by Inari Medical, Inc. https://foiadocs.com/products/fda-510k-k021477-preclude-mvp-dura-substitute 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K021477, PRECLUDE MVP DURA SUBSTITUTE, by W. L. Gore & Associates, Inc. https://foiadocs.com/products/fda-510k-k984534-preclude-acuseal-dura-substitute 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K984534, PRECLUDE ACUSEAL DURA SUBSTITUTE, by W. L. Gore & Associates, Inc. https://foiadocs.com/products/fda-510k-k012098-preclude-pericardial-membrane 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K012098, PRECLUDE PERICARDIAL MEMBRANE, by W. L. Gore & Associates, Inc. https://foiadocs.com/products/fda-510k-k130148-foreign-body-hood 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130148, FOREIGN BODY HOOD, by United States Endoscopy Group, Inc. https://foiadocs.com/products/fda-510k-k913749-edentrace-airflow-3171-sleep-lab-airflow-3170 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K913749, EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170, by Edentec Corp. https://foiadocs.com/products/fda-510k-k143153-evis-exera-ii-duodenovideoscope-olympus-tjf-type-q180v 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143153, EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V, by Olympus Medical Systems Corp. https://foiadocs.com/products/fda-510k-k123935-ihealth-bg5-bg5l-wireless-smart-glucose-monitoring-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123935, IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM, by Andon Medical Co., Ltd. https://foiadocs.com/products/fda-510k-k031861-mix2vial-transfer-device 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K031861, MIX2VIAL TRANSFER DEVICE, by Medimop Medical Projects, Ltd. https://foiadocs.com/products/fda-510k-k161201-clearread-ct 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161201, ClearRead CT, by Riverain Technologies, LLC https://foiadocs.com/products/fda-510k-k120561-neuroblate-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120561, NEUROBLATE SYSTEM, by Monteris Medical, Inc. https://foiadocs.com/products/fda-510k-k131278-monteris-medical-neuroblate-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131278, MONTERIS MEDICAL NEUROBLATE SYSTEM, by Monteris Medical, Inc. https://foiadocs.com/products/fda-510k-k130387-orthoalign-plus-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130387, ORTHOALIGN PLUS SYSTEM, by Orthalign, Inc. https://foiadocs.com/products/fda-510k-k143646-mr810-system-900mr810-adult-single-limb-circuit-900mr810e-adult-dual-limb-circuit 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143646, MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit, by Fisher & Paykel Healthcare, Ltd. https://foiadocs.com/products/fda-510k-k072845-precision-flow 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K072845, PRECISION FLOW, by Vapotherm, Inc. https://foiadocs.com/products/fda-510k-k151149-ready-fit 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151149, Ready-Fit, by Den Tek Oral Care, Inc. https://foiadocs.com/products/fda-510k-k161266-athena-breast-pump 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161266, Athena Breast Pump, by Exploramed Nc7, Inc. https://foiadocs.com/products/fda-510k-k133317-penumbra-system-penumbra-system-max 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133317, PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX, by Penumbra, Inc. https://foiadocs.com/products/fda-510k-k160959-xsert-lumbar-expandable-interbody-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160959, Xsert Lumbar Expandable Interbody System, by X-Spine Systems, Inc. https://foiadocs.com/products/fda-510k-k970685-earcheck-pro 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K970685, EARCHECK PRO, by Mdi Instruments, Inc. https://foiadocs.com/products/fda-510k-k070374-arthrocare-ent-plasma-wand 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K070374, ARTHROCARE ENT PLASMA WAND, by Arthrocare Corp. https://foiadocs.com/products/fda-510k-k882963-spembly-medical-142-cryo-unit 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K882963, SPEMBLY MEDICAL 142 CRYO UNIT, by Spembly Medical , Ltd. https://foiadocs.com/products/fda-510k-k102409-defendo-disposable-air-water-valve-model-100304 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K102409, DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304, by Byrne Medical, Inc. https://foiadocs.com/products/fda-510k-k001275-retcam-ii 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K001275, RETCAM II, by Massie Research Laboratories, Inc. https://foiadocs.com/products/fda-510k-k043401-spectranetics-lld-cs-model-518-039 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K043401, SPECTRANETICS LLD CS, MODEL 518-039, by Spectranetics Corp. https://foiadocs.com/products/fda-510k-k001338-microvasive-rapid-exchange-biliary-balloon-dilatation-catheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K001338, MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER, by Boston Scientific Corp https://foiadocs.com/products/fda-510k-k153645-vita-enamic-implant-solutions-is 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153645, VITA ENAMIC Implant Solutions (IS), by Vita Zahnfabrik H.Rauter GmbH Co. https://foiadocs.com/products/fda-510k-k141668-cusa-excel-ultrasonic-surgical-aspirator-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141668, CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM, by Integra LifeSciences Corporation https://foiadocs.com/products/fda-510k-k143538-mrxperion-mr-injection-system-mrxperion-mr-injection-system-syringe-kit 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143538, MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit, by Bayer Medical Care, Inc. https://foiadocs.com/products/fda-510k-k030382-selitherm-model-c100 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K030382, SELITHERM, MODEL C100, by Selicor, Inc. https://foiadocs.com/products/fda-510k-k080403-xtjf-type-q160vf1 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080403, XTJF TYPE Q160VF1, by Olympus Medical Systems Corporation https://foiadocs.com/products/fda-510k-k140996-mammi 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140996, MAMMI, by General Equipment For Medical Imaging (Oncovision- https://foiadocs.com/products/fda-510k-k050993-mms-video-option 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K050993, MMS VIDEO OPTION, by Medical Measurement Systems B.V. https://foiadocs.com/products/fda-510k-k111495-cook-gi-endoscopic-injection-gel-kit-gel-s-gel-n-gel-h-gel-k 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K111495, COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K, by Wilson-Cook Medical, Inc. https://foiadocs.com/products/fda-510k-k112930-mobile-mim 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K112930, MOBILE MIM, by Mim Software, Inc. https://foiadocs.com/products/fda-510k-k002911-xscan32-teleradiology-software 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K002911, XSCAN32 TELERADIOLOGY SOFTWARE, by Radiographic Digital Imaging, Inc. https://foiadocs.com/products/fda-510k-k963160-hx-5-6-1-endoscopic-clipping-device 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K963160, HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, by Olympus America, Inc. https://foiadocs.com/products/fda-510k-k033337-ultrapro-mesh 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K033337, ULTRAPRO MESH, by ETHICON, Inc. https://foiadocs.com/products/fda-510k-k150154-anam-test-system-military-battery 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150154, ANAM Test System: Military Battery, by Vista Lifesciences, Inc. https://foiadocs.com/products/fda-510k-k111346-resolutionmd-mobile-model-rmb-mob-2x 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K111346, RESOLUTIONMD MOBILE MODEL RMB-MOB-2X, by Calgary Scientific, Inc. https://foiadocs.com/products/fda-510k-k130581-konix-sterile-gel 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130581, KONIX STERILE GEL, by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa https://foiadocs.com/products/fda-510k-k820227-ster-o-dose 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K820227, STER-O-DOSE, by Inhalation Therapy Equipment, Co. https://foiadocs.com/products/fda-510k-k032222-immunocardstat-hpsa 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K032222, IMMUNOCARDSTAT HPSA, by Meridian Bioscience, Inc. https://foiadocs.com/products/fda-510k-k855121-coloshield-kit 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K855121, COLOSHIELD KIT, by Deknatel, Inc. https://foiadocs.com/products/fda-510k-k162176-fiagon-navigation-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K162176, Fiagon Navigation System, by Fiagon GmbH https://foiadocs.com/products/fda-510k-k142458-penumbra-system-ace 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142458, Penumbra System ACE, by Penumbra, Inc. https://foiadocs.com/products/fda-510k-k043272-pallindrome-14-5fr-chronic-hemodialysis-catheter-with-slotted-symmetrical-tip 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K043272, PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP, by Kendall https://foiadocs.com/products/fda-510k-k102871-silver-care-anitbacterial-toothbrush 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K102871, SILVER CARE ANITBACTERIAL TOOTHBRUSH, by Piave Spazzolificio S.P.A. https://foiadocs.com/products/fda-510k-k012530-aa-1-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K012530, AA-1 SYSTEM, by Neurovision, Inc. https://foiadocs.com/products/fda-510k-k100559-myosure-hysteroscopic-tissue-removal-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100559, MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM, by Interlace Medical, Inc. https://foiadocs.com/products/fda-510k-k021473-bair-hugger-temperature-management-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K021473, BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM, by Augustine Medical, Inc. https://foiadocs.com/products/fda-510k-k053645-modification-to-bair-hugger-temperature-management-systems 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K053645, MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS, by Arizant Healthcare, Inc. https://foiadocs.com/products/fda-510k-k041686-bair-hugger-temperature-management-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K041686, BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM, by Arizant Healthcare, Inc. https://foiadocs.com/products/fda-510k-k041363-aoc-bone-wax 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K041363, AOC BONE WAX, by Ceremed , Inc. https://foiadocs.com/products/fda-510k-k042200-mi-paste 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042200, MI PASTE, by GC America, Inc. https://foiadocs.com/products/fda-510k-k112605-sysmex-xn-series 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K112605, SYSMEX XN-SERIES, by Sysmex America, Inc. https://foiadocs.com/products/fda-510k-k121735-fiber-disk-and-block-permanent-trinia 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121735, FIBER DISK AND BLOCK PERMANENT, TRINIA, by Bioloren S.R.L. https://foiadocs.com/products/fda-510k-k050574-afinion-hbalc 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K050574, AFINION HBALC, by Axis-Shield Poc AS https://foiadocs.com/products/fda-510k-k050516-t-sling 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K050516, T-SLING, by Herniamesh S.R.L. https://foiadocs.com/products/fda-510k-k030882-rabbit-mobile-standing-frame 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K030882, RABBIT MOBILE STANDING FRAME, by R82 A/S https://foiadocs.com/products/fda-510k-k111170-pico 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K111170, PICO, by Smith & Nephew, Inc. https://foiadocs.com/products/fda-510k-k142122-radar-vascular-compression-device 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142122, RADAR VASCULAR COMPRESSION DEVICE, by Advanced Vascular Dynamics https://foiadocs.com/products/fda-510k-k100384-fiberlase-c02-laser-waveguide 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100384, FIBERLASE C02 LASER WAVEGUIDE, by Lumenis, Ltd. https://foiadocs.com/products/fda-510k-k863872-tamper-hamper 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K863872, TAMPER HAMPER, by Hydro-Med Products, Inc. https://foiadocs.com/products/fda-510k-k093489-in-vision-plus-nano-with-neutral-advantage-technology 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093489, IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY, by Rymed Technologies, Inc. https://foiadocs.com/products/fda-510k-k142646-xlr8-white-foam-dressing-kit-and-xlr8-white-foam-small-dressing-kit-and 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142646, XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and, by Genadyne Biotechnologies, Inc. https://foiadocs.com/products/fda-510k-k021746-sqa-v-sperm-quality-analyzer 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K021746, SQA V, SPERM QUALITY ANALYZER, by Medical Electronic Systems, LLC https://foiadocs.com/products/fda-510k-k012805-automarqer 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K012805, AUTOMARQER, by Hamilton Thorne Research https://foiadocs.com/products/fda-510k-k012352-sqa-sperm-quality-analyzer 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K012352, SQA, SPERM QUALITY ANALYZER, by Medical Electronic Systems, LLC https://foiadocs.com/products/fda-510k-k150407-bioflo-midline-catheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150407, BioFlo Midline Catheter, by Navilyst Medical, Inc. https://foiadocs.com/products/fda-510k-k113862-zio-patch 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K113862, ZIO PATCH, by iRhythm Technologies, Inc. https://foiadocs.com/products/fda-510k-k061855-neuroquant 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061855, NEUROQUANT, by Cortechs Labs, Inc. https://foiadocs.com/products/fda-510k-k161631-mammi 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161631, MAMMI, by General Equipment For Medical Imaging https://foiadocs.com/products/fda-510k-k922186-hem-o-lok-modification 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K922186, HEM-O-LOK -- MODIFICATION, by Linvatec Corp. https://foiadocs.com/products/fda-510k-k982941-hem-o-lok-model-numbers-523900-523970 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K982941, HEM-O-LOK MODEL NUMBERS 523900, 523970, by Weck Closure Systems https://foiadocs.com/products/fda-510k-k993157-hem-o-lok-smx-polymer-clips-model-544220-hem-0-lok-mlx-polymer-clips-model-544240 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K993157, HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240, by Weck Closure Systems https://foiadocs.com/products/fda-510k-k040417-pillar-palatal-implant-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K040417, PILLAR PALATAL IMPLANT SYSTEM, by Restore Medical, Inc. https://foiadocs.com/products/fda-510k-k121275-aquacel-ag-extra-hydrofiber-dressing-with-silver-and-strengthening-fiber 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121275, AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER, by Convatec, Inc. https://foiadocs.com/products/fda-510k-k042172-cleo-90-infusion-set 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042172, CLEO 90 INFUSION SET, by Smiths Medical MD, Inc. https://foiadocs.com/products/fda-510k-k041007-millenium-models-2000-2001-and-2002 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K041007, MILLENIUM, MODELS 2000, 2001 AND 2002, by Hyperbaric For Life, LLC https://foiadocs.com/products/fda-510k-k982597-fibrcol-plus-collagen-wound-dressing-with-alginate 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K982597, FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE, by Johnson & Johnson Medical, Inc. https://foiadocs.com/products/fda-510k-k130210-medela-thopaz 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130210, MEDELA THOPAZ, by Medela AG https://foiadocs.com/products/fda-510k-k001781-curry-multimodal-neuroimaging-software 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K001781, CURRY MULTIMODAL NEUROIMAGING SOFTWARE, by Neurosoft, Inc. https://foiadocs.com/products/fda-510k-k802146-aquasonic-100-ultrasound-trans-gel 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K802146, AQUASONIC 100 ULTRASOUND TRANS. GEL,, by Parker Laboratories, Inc. https://foiadocs.com/products/fda-510k-k122801-providence-cervical-cage 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122801, PROVIDENCE CERVICAL CAGE, by Providence Medical Technology, Inc. https://foiadocs.com/products/fda-510k-k083526-trilogy-100-ventilator 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K083526, TRILOGY 100 VENTILATOR, by Respironics Inc., Sleep & Home Respiratory Group https://foiadocs.com/products/fda-510k-k932786-ucs-1000tm-with-tonguetouch-keypad-wheelchair 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K932786, UCS 1000(TM) WITH TONGUETOUCH KEYPAD WHEELCHAIR, by New Abilities Systems, Inc. https://foiadocs.com/products/fda-510k-k974393-vaso-press-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K974393, VASO PRESS SYSTEM, by Britt Corp., Inc. https://foiadocs.com/products/fda-510k-k163475-ivue 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K163475, iVue, by Optovue, Inc. https://foiadocs.com/products/fda-510k-k002892-frsenius-pd-iqcard-cycler 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K002892, FRSENIUS PD IQCARD CYCLER, by Fresenius Medical Care North America https://foiadocs.com/products/fda-510k-k101241-replens-long-lasting-vaginal-moisturizer-pre-filled-applicator 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K101241, REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR), by Lil Drug Store Products, Inc. https://foiadocs.com/products/fda-510k-k150883-hyalogyn-vaginal-hydrating-gel 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150883, HyaloGYN Vaginal Hydrating Gel, by Fidia Farmaceutici S.P.A. https://foiadocs.com/products/fda-510k-k021737-rephresh-vaginal-gel 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K021737, REPHRESH VAGINAL GEL, by Columbia Laboratories, Inc. https://foiadocs.com/products/fda-510k-k970321-bio-oss-anorganic-bovine-bone 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K970321, BIO-OSS ANORGANIC BOVINE BONE, by Geistlich-Pharma https://foiadocs.com/products/fda-510k-k113658-amplatzer-vascular-plug-4 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K113658, AMPLATZER VASCULAR PLUG 4, by Aga Medical Corp. https://foiadocs.com/products/fda-510k-k133924-endoluminal-occlusion-system-eos 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133924, ENDOLUMINAL OCCLUSION SYSTEM (EOS), by Artventive Medical Group, Inc. https://foiadocs.com/products/fda-510k-k781892-locator-foreign-body 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K781892, LOCATOR, FOREIGN BODY, by Keeler Optical Products , Ltd. https://foiadocs.com/products/fda-510k-k911886-pmt-metal-locator-model-3630-1 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K911886, PMT METAL LOCATOR, MODEL 3630-1, by Pmt Corp. https://foiadocs.com/products/fda-510k-k953277-shadow-medal-locator 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K953277, SHADOW MEDAL LOCATOR, by Fatswith Intl., Inc. https://foiadocs.com/products/fda-510k-k952882-personal-telemedicine-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K952882, PERSONAL TELEMEDICINE SYSTEM, by American Telecare, Inc. https://foiadocs.com/products/fda-510k-k973873-digital-personal-telemedicine-module-digital-ptm-1 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K973873, DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1, by American Telecare, Inc. https://foiadocs.com/products/fda-510k-k964554-personal-telemedicine-module 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K964554, PERSONAL TELEMEDICINE MODULE, by American Telecare, Inc. https://foiadocs.com/products/fda-510k-k120009-testosterone-test-system-calibrator-and-quality-control-material-assayed-and-unassayed 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120009, TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED), by Abbott Laboratories https://foiadocs.com/products/fda-510k-k032465-mini-l-e-d-model-mini-l-e-d-model-smartlite-mini 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K032465, MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI, by Satelec https://foiadocs.com/products/fda-510k-k940466-titanium-bipolar-forceps 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K940466, TITANIUM BIPOLAR FORCEPS, by Radionics, Inc. https://foiadocs.com/products/fda-510k-k173388-exactech-equinoxe-stemless-shoulder 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173388, Exactech Equinoxe Stemless Shoulder, by Exactech, Inc. https://foiadocs.com/products/fda-510k-k023086-classic-great-toe-implant 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K023086, CLASSIC GREAT TOE IMPLANT, by Nexa Orthopedics, Inc. https://foiadocs.com/products/fda-510k-k023562-modification-to-classic-great-toe-implant 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K023562, MODIFICATION TO CLASSIC GREAT TOE IMPLANT, by Nexa Orthopedics, Inc. https://foiadocs.com/products/fda-510k-k142107-echo-true-3d-viewer 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142107, ECHO TRUE 3D VIEWER, by Echopixel, Inc. https://foiadocs.com/products/fda-510k-k912938-rhythm 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K912938, RHYTHM, by Stellate Systems https://foiadocs.com/products/fda-510k-k010728-harmone-schwarzer-eeg-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K010728, HARMONE-SCHWARZER EEG SYSTEM, by Stellate Systems https://foiadocs.com/products/fda-510k-k093934-gore-hybrid-vascular-graft 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093934, GORE HYBRID VASCULAR GRAFT, by W.L. Gore & Associates https://foiadocs.com/products/fda-510k-k884888-modified-new-jersey-acetabular-comp-bone-screws 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K884888, MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS, by Protek, Inc. https://foiadocs.com/products/fda-510k-k063379-amedica-drug-screen-thc-coc-opi-amp-met-pcp-mdma-bar-bzo-m-models-c1210-c1220 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K063379, AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220, by Amedica Biotech, Inc. https://foiadocs.com/products/fda-510k-k010139-zurich-distraction-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K010139, ZURICH DISTRACTION SYSTEM, by KLS-Martin L.P. https://foiadocs.com/products/fda-510k-k964034-transjugular-access-set 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K964034, TRANSJUGULAR ACCESS SET, by AngioDynamics, Inc. https://foiadocs.com/products/fda-510k-k031804-compress-distal-femoral-replacement 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K031804, COMPRESS DISTAL FEMORAL REPLACEMENT, by Biomet, Inc. https://foiadocs.com/products/fda-510k-k041352-compress-distal-femoral-replacement-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K041352, COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM, by Biomet, Inc. https://foiadocs.com/products/fda-510k-k043547-compress-segmental-femoral-replacement-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K043547, COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM, by Biomet, Inc. https://foiadocs.com/products/fda-510k-k781967-hemodialysis-concentrate-sodiu 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K781967, HEMODIALYSIS CONCENTRATE, SODIU, by Renal Systems, Inc. https://foiadocs.com/products/fda-510k-k092926-acell-matristem-wound-sheet 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092926, ACELL MATRISTEM WOUND SHEET, by Acell, Inc. https://foiadocs.com/products/fda-510k-k070961-biomerix-surgical-mesh-model-rcr-01 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K070961, BIOMERIX SURGICAL MESH, MODEL: RCR-01, by Biomerix Corporation https://foiadocs.com/products/fda-510k-k082327-invos-cerebral-somatic-oximeter-system-model-5100c 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082327, INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C, by Somanetics Corp. https://foiadocs.com/products/fda-510k-k083752-gluseal-90-model-glu9010 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K083752, GLUSEAL 90, MODEL GLU9010, by Glustitch, Inc. https://foiadocs.com/products/fda-510k-k122158-pbp-total-hip-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122158, PBP TOTAL HIP SYSTEM, by Pipeline Biomedical Products, LLC https://foiadocs.com/products/fda-510k-k162207-restore-moisturizing-vaginal-lubricant 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K162207, Restore Moisturizing Vaginal Lubricant, by Good Clean Love https://foiadocs.com/products/fda-510k-k141718-internal-hydrating-gel 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141718, INTERNAL HYDRATING GEL, by Combe Incorporated https://foiadocs.com/products/fda-510k-k031786-tne-2000-esophagoscope-with-ecs-d-endosheath-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K031786, TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM, by Vision-Sciences, Inc. https://foiadocs.com/products/fda-510k-k100821-prevena-incision-management-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100821, PREVENA INCISION MANAGEMENT SYSTEM, by Kci USA, Inc. https://foiadocs.com/products/fda-510k-k140190-night-shift 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140190, NIGHT SHIFT, by Advanced Brain Monitoring, Inc. https://foiadocs.com/products/fda-510k-k171135-lipogems-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171135, Lipogems System, by Lipogems International Spa https://foiadocs.com/products/fda-510k-k880038-for-the-deter-of-hemoglobin-in-plasma-527 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K880038, FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527, by Sigma Diagnostics, Inc. https://foiadocs.com/products/fda-510k-k910091-ultralite-panelite 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K910091, ULTRALITE PANELITE, by Ultralite https://foiadocs.com/products/fda-510k-k843758-uropaper-eiken-gk 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K843758, UROPAPER EIKEN GK, by Syn-Kit, Inc. https://foiadocs.com/products/fda-510k-k843755-uropaper-eiken-6b 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K843755, UROPAPER EIKEN 6B, by Syn-Kit, Inc. https://foiadocs.com/products/fda-510k-k843756-uropaper-eiken-5 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K843756, UROPAPER EIKEN 5, by Syn-Kit, Inc. https://foiadocs.com/products/fda-510k-k843754-uropaper-eiken-7 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K843754, UROPAPER EIKEN 7, by Syn-Kit, Inc. https://foiadocs.com/products/fda-510k-k932363-uropaper-eiken-gk 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K932363, UROPAPER EIKEN GK, by Tanabe U.S.A., Inc. https://foiadocs.com/products/fda-510k-k843753-uropaper-eiken-gp 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K843753, UROPAPER EIKEN GP, by Syn-Kit, Inc. https://foiadocs.com/products/fda-510k-k932369-uropaper-eiken-7 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K932369, UROPAPER EIKEN 7, by Tanabe U.S.A., Inc. https://foiadocs.com/products/fda-510k-k932364-uropaper-eiken-gp 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K932364, UROPAPER EIKEN GP, by Tanabe U.S.A., Inc. https://foiadocs.com/products/fda-510k-k932368-uropaper-eiken-6b 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K932368, UROPAPER EIKEN 6B, by Tanabe U.S.A., Inc. https://foiadocs.com/products/fda-510k-k932366-uropaper-eiken-hag 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K932366, UROPAPER EIKEN HAG, by Tanabe U.S.A., Inc. https://foiadocs.com/products/fda-510k-k843532-uropaper-eiken-8 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K843532, UROPAPER EIKEN 8, by Syn-Kit, Inc. https://foiadocs.com/products/fda-510k-k932367-uropaper-eiken-8 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K932367, UROPAPER EIKEN 8, by Tanabe U.S.A., Inc. https://foiadocs.com/products/fda-510k-k946106-gore-tex-dualmesh-plus-biomaterial 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K946106, GORE-TEX DUALMESH PLUS BIOMATERIAL, by W. L. Gore & Associates, Inc. https://foiadocs.com/products/fda-510k-k063435-gore-dualmesh-plus-biomaterial-gore-mycromesh-plus-biomaterial 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K063435, GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL, by W. L. Gore & Associates, Inc. https://foiadocs.com/products/fda-510k-k843759-uropaper-eiken-hag 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K843759, UROPAPER EIKEN HAG, by Syn-Kit, Inc. https://foiadocs.com/products/fda-510k-k811818-uropaper-eiken-uag 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K811818, UROPAPER EIKEN UAG, by Syn-Kit, Inc. https://foiadocs.com/products/fda-510k-k811817-uropaper-eiken-ag 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K811817, UROPAPER EIKEN AG, by Syn-Kit, Inc. https://foiadocs.com/products/fda-510k-k151909-noris-medical-zygomatic-dental-implant-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151909, Noris Medical Zygomatic Dental Implant System, by Noris Medical , Ltd. https://foiadocs.com/products/fda-510k-k960791-karl-storz-huzly-high-frequency-cutting-loops 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K960791, KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS, by KARL STORZ Endoscopy-America, Inc. https://foiadocs.com/products/fda-510k-k141053-ovine-tissue-matrixotm 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141053, OVINE TISSUE MATRIX(OTM), by TELA Bio, Inc. https://foiadocs.com/products/fda-510k-k944650-wang-bronchial-needle-brush 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K944650, WANG BRONCHIAL NEEDLE BRUSH, by Mill-Rose Laboratory https://foiadocs.com/products/fda-510k-k780872-cytology-brush 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K780872, CYTOLOGY BRUSH, by CooperVision, Inc. https://foiadocs.com/products/fda-510k-k032104-amniolens 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K032104, AMNIOLENS, by Bio-Tissue, Inc. https://foiadocs.com/products/fda-510k-k082891-lenstar-model-ls900 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082891, LENSTAR, MODEL LS900, by Haag-Streit AG https://foiadocs.com/products/fda-510k-k924165-optisol-gs-corneal-storage-media 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K924165, OPTISOL-GS CORNEAL STORAGE MEDIA, by Chiron Intraoptics https://foiadocs.com/products/fda-510k-k001277-triflange-acetabular-cup-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k), K001277, TRIFLANGE ACETABULAR CUP SYSTEM https://foiadocs.com/products/fda-510k-k980025-peregrine-tapered-diffusion-probe 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K980025, PEREGRINE TAPERED DIFFUSION PROBE, by Peregrine Surgical , Ltd. https://foiadocs.com/products/fda-510k-k980027-peregrine-shielded-diffusion-probe 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K980027, PEREGRINE SHIELDED DIFFUSION PROBE, by Peregrine Surgical , Ltd. https://foiadocs.com/products/fda-510k-k110268-forcetriad-electrosurgical-generator 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110268, FORCETRIAD ELECTROSURGICAL GENERATOR, by Covidien Lp, Formerly Know AS Valleylab, A Divison https://foiadocs.com/products/fda-510k-k141770-luna-cpap-and-auto-cpap-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141770, LUNA CPAP AND AUTO-CPAP SYSTEM, by 3B Medical, Inc. https://foiadocs.com/products/fda-510k-k962928-combined-intracranial-pressure-temperature-sensing-system-icp 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K962928, COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/), by Camino Neurocare, Inc. https://foiadocs.com/products/fda-510k-k171816-kardia-band-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171816, Kardia Band System, by AliveCor, Inc. https://foiadocs.com/products/fda-510k-k030554-callos 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K030554, CALLOS, by Skeletal Kinetics, LLC https://foiadocs.com/products/fda-510k-k912702-plastic-attachable-dual-port 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K912702, PLASTIC ATTACHABLE DUAL PORT, by Davol, Inc. https://foiadocs.com/products/fda-510k-k020530-evans-sub-q-model-mc4206 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K020530, EVANS SUB-Q, MODEL MC4206, by Evans Medical, Inc. https://foiadocs.com/products/fda-510k-k080092-elecsys-anti-tshr-immunoassay-elecsys-precicontrol-thyroab 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080092, ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB, by Roche Diagnostics Corp. https://foiadocs.com/products/fda-510k-k181704-transpara 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K181704, Transpara, by Screenpoint Medical B.V. https://foiadocs.com/products/fda-510k-k911590-immunowell-borrelia-lymetest 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K911590, IMMUNOWELL BORRELIA (LYME)TEST, by General Biometrics, Inc. https://foiadocs.com/products/fda-510k-k032288-vitoss-scaffold-foam-bone-graft-material 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K032288, VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL, by Orthovita, Inc. https://foiadocs.com/products/fda-510k-k083020-stryker-spine-reflex-translational-anterior-cervical-plating-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K083020, STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEM, by Stryker Corp. https://foiadocs.com/products/fda-510k-k051665-synthes-vectra-t-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K051665, SYNTHES VECTRA-T SYSTEM, by Synthes Spine https://foiadocs.com/products/fda-510k-k911599-immunowell-lyme-p39-recombinant-test 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K911599, IMMUNOWELL LYME (P39 RECOMBINANT) TEST, by General Biometrics, Inc. https://foiadocs.com/products/fda-510k-k911627-immunodot-borrelia-lyme-test 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K911627, IMMUNODOT BORRELIA (LYME) TEST, by General Biometrics, Inc. https://foiadocs.com/products/fda-510k-k891696-duoderm-extra-thin-flexible-hydrocolloid-dressing 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K891696, DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING, by Convatec, A Division of E.R. Squibb & Sons https://foiadocs.com/products/fda-510k-k925990-duoderm-extra-thin-cgf-dressing 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K925990, DUODERM EXTRA THIN CGF DRESSING, by Convatec, A Division of E.R. Squibb & Sons https://foiadocs.com/products/fda-510k-k973716-duoderm-extra-thin-cgf-dressing 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K973716, DUODERM EXTRA THIN CGF DRESSING, by Convatec, A Bristol-Myers Squibb Co. https://foiadocs.com/products/fda-510k-k072834-sibel-sa-vascular-clamp 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K072834, SIBEL SA VASCULAR CLAMP, by Surgical Instruments Belgium SA https://foiadocs.com/products/fda-510k-k013110-aniseikonia-inspector 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K013110, ANISEIKONIA INSPECTOR, by Optical Diagnostics, Inc. https://foiadocs.com/products/fda-510k-k841202-dacomed-rigiscan-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K841202, DACOMED RIGISCAN SYSTEM, by Dacomed Corp. https://foiadocs.com/products/fda-510k-k941781-rigiscan-plus-rigidity-assessment-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K941781, RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM, by Dacomed Corp. https://foiadocs.com/products/fda-510k-k062042-plethora-solutions-sexual-assessment-monitor-sam 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062042, PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM), by Plethora Solutions https://foiadocs.com/products/fda-510k-k173651-multiple-tubing-segment-set-with-stay-safe-pin-connectors-stay-safe-drain-set 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173651, Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set, by Fresenius Medical Care Renal Therapies Group, LLC https://foiadocs.com/products/fda-510k-k923065-baxter-personal-cycler-autommated-peritoneal-dial 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K923065, BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL, by Baxter Healthcare Corp https://foiadocs.com/products/fda-510k-k162513-arterys-software-v2-0 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K162513, Arterys Software v2.0, by Arterys, Inc. https://foiadocs.com/products/fda-510k-k012670-boss-2000-3-vacuum-erection-device 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K012670, BOSS 2000-3 VACUUM ERECTION DEVICE, by Pos-T-Vac, Inc. https://foiadocs.com/products/fda-510k-k002571-mulitple-male-latx-condom 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K002571, MULITPLE MALE LATX CONDOM, by Pleasure Latex Products Sdn. Bhd. https://foiadocs.com/products/fda-510k-k951104-endoboot 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K951104, ENDOBOOT, by United States Endoscopy Group, Inc. https://foiadocs.com/products/fda-510k-k120906-zimmer-trabecular-metal-total-ankle 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120906, ZIMMER TRABECULAR METAL TOTAL ANKLE, by Zimmer, Inc. https://foiadocs.com/products/fda-510k-k130223-rmgi-fill 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130223, RMGI FILL, by Pulpdent Corporation https://foiadocs.com/products/fda-510k-k123265-rmgi-low-viscosity 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123265, RMGI LOW VISCOSITY, by Pulpdent Corporation https://foiadocs.com/products/fda-510k-k963141-kugel-hernia-patch 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K963141, KUGEL HERNIA PATCH, by Douglas Bueschel https://foiadocs.com/products/fda-510k-k043371-biomerix-vascular-occlusion-device-and-loader 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K043371, BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER, by Biomerix Corporation https://foiadocs.com/products/fda-510k-k132343-marigen-wound-dressing 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132343, MARIGEN WOUND DRESSING, by Kerecis Limited https://foiadocs.com/products/fda-510k-k063349-cormatrix-patch-for-cardiac-tissue-repair 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K063349, CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR, by Cormatrix Cardiovascular, Inc. https://foiadocs.com/products/fda-510k-k173420-radiomics-app-v1-0 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173420, Radiomics App v1.0, by Microsoft Corp. https://foiadocs.com/products/fda-510k-k040011-polaris-2004-capnograph 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K040011, POLARIS 2004 CAPNOGRAPH, by Oridion , Ltd. https://foiadocs.com/products/fda-510k-k060065-capnostream20-two-parameter-bedside-monitor-capnostream10-one-parameter-bedside-monitor 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K060065, CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR, by Oridion Capnography, Inc. https://foiadocs.com/products/fda-510k-k950388-polaris 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K950388, POLARIS, by Spegas Industries, Ltd. https://foiadocs.com/products/fda-510k-k860737-teen-clean-retainer-cleaner 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K860737, TEEN CLEAN, RETAINER CLEANER, by Teen Care, Inc. https://foiadocs.com/products/fda-510k-k081010-bard-3dmax-mesh 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K081010, BARD 3DMAX MESH, by Davol Inc., Sub. C. R. Bard, Inc. https://foiadocs.com/products/fda-510k-k922916-bard-marlex-mesh-dart 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K922916, BARD MARLEX MESH DART, by C.R. Bard, Inc. https://foiadocs.com/products/fda-510k-k061771-ez-connect 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061771, EZ-CONNECT, by Vidacare Corporation https://foiadocs.com/products/fda-510k-k153754-micromatrix 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153754, MicroMatrix, by Acell, Inc. https://foiadocs.com/products/fda-510k-k140342-qct-pro-asynchronous-calibration-module-cliniqct 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140342, QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT, by Mindways Software, Inc. https://foiadocs.com/products/fda-510k-k150476-spectra-s1plus-and-spectra-s2-plus 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150476, Spectra S1Plus and Spectra S2 Plus, by Uzinmedicare Co. https://foiadocs.com/products/fda-510k-k120425-pentaray-nav-high-density-mapping-catheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120425, PENTARAY NAV HIGH-DENSITY MAPPING CATHETER, by Biosense Webster, Inc. https://foiadocs.com/products/fda-510k-k002699-parietex-composite-pco-mesh 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K002699, PARIETEX COMPOSITE (PCO) MESH, by Medical Device Consultants, Inc. https://foiadocs.com/products/fda-510k-k092573-nihon-kohden-qp-160ak-eeg-trend-program 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092573, NIHON KOHDEN QP-160AK EEG TREND PROGRAM, by Nihon Kohden America, Inc. https://foiadocs.com/products/fda-510k-k151325-bovie-j-plasma-handpiece 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151325, Bovie J-Plasma Handpiece, by Bovie Medical Corporation https://foiadocs.com/products/fda-510k-k173553-lucas-3-chest-compression-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173553, LUCAS 3 Chest Compression System, by Jolife AB https://foiadocs.com/products/fda-510k-k151313-zelantedvt-thrombectomy-set 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151313, ZelanteDVT Thrombectomy Set, by Boston Scientific Corporation https://foiadocs.com/products/fda-510k-k161355-invendoscopy-e200-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161355, invendoscopy E200 System, by Invendo Medical GmbH https://foiadocs.com/products/fda-510k-k173085-invendoscopy-e210-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173085, invendoscopy E210 System, by Invendo Medical GmbH https://foiadocs.com/products/fda-510k-k142806-dualcap 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142806, DualCap, by Catheter Connections, Inc. https://foiadocs.com/products/fda-510k-k171610-mc3-quickflow-dual-lumen-catheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171610, MC3 QuickFlow Dual Lumen Catheter, by Mc3 Incorporated https://foiadocs.com/products/fda-510k-k141983-neuroblate-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141983, NEUROBLATE SYSTEM, by Monteris Medical Corp. https://foiadocs.com/products/fda-510k-k181965-restore-toothpaste 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K181965, Restore Toothpaste, by Dr. Collins, Inc. https://foiadocs.com/products/fda-510k-k183282-biovitals-analytics-engine 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K183282, Biovitals Analytics Engine, by Biofourmis Singapore Pte., Ltd. https://foiadocs.com/products/fda-510k-k173681-reset-o 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173681, reSET-O, by Pear Therapeutics, Inc. https://foiadocs.com/products/fda-510k-k180233-eviva-stereotactic-guided-breast-biopsy-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K180233, Eviva Stereotactic Guided Breast Biopsy System, by Hologic, Inc. https://foiadocs.com/products/fda-510k-k183091-elaris-pedicle-screw-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K183091, Elaris Pedicle Screw System, by Spinewelding AG https://foiadocs.com/products/fda-510k-k190898-sight-olo 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190898, Sight OLO, by Sight Diagnostics , Ltd. https://foiadocs.com/products/fda-510k-k142061-silhouette-instalift 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142061, SILHOUETTE INSTALIFT, by Silhouette Lift, Inc. https://foiadocs.com/products/fda-510k-k173450-press-duo-elite-press-duo-elite-ag 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173450, PRESS DUO elite, PRESS DUO elite AG, by Nemoto Kyorindo Co., Ltd. https://foiadocs.com/products/fda-510k-k171566-atellica-im-high-sensitivity-troponin-i-tnih 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171566, Atellica IM High-Sensitivity Troponin I (TNIH), by Siemens Healthcare Diagnostics, Inc. https://foiadocs.com/products/fda-510k-k163234-biograph-mmr-with-syngo-mr-e11p-system-software 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K163234, Biograph mMR with syngo MR E11P system software, by Siemens Medical Solutions USA, Inc. https://foiadocs.com/products/fda-510k-k172457-deltex-medical-cardioq-edm-deltex-medical-cardioq-edm 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K172457, Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM, by Deltex Medical Limited https://foiadocs.com/products/fda-510k-k142932-deltex-medical-kdp72-doppler-probe 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142932, Deltex Medical KDP72 Doppler Probe, by Deltex Medical Limited https://foiadocs.com/products/fda-510k-k052989-dp240-240-hour-doppler-probe 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K052989, DP240 240 HOUR DOPPLER PROBE, by Deltex Medical https://foiadocs.com/products/fda-510k-k183319-triangle-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K183319, Triangle System, by AliveCor, Inc. https://foiadocs.com/products/fda-510k-k171637-opclear-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171637, OpClear System, by Cipher Surgical, Ltd. https://foiadocs.com/products/fda-510k-k172322-atellica-im-total-hcg-thcg 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K172322, Atellica IM Total hCG (ThCG), by Siemens Healthcare Diagnostics, Inc. https://foiadocs.com/products/fda-510k-k172627-david-home-pregnancy-test-cassette-david-professional-pregnancy-test-cassette 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K172627, David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette, by Runbio Biotech Co.,Ltd https://foiadocs.com/products/fda-510k-k182826-ormco-spark-aligner-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182826, Ormco Spark Aligner System, by Sybron Dental Specialties https://foiadocs.com/products/fda-510k-k163689-3m-clear-tray-aligner 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K163689, 3M Clear Tray Aligner, by 3M Unitek Corporation https://foiadocs.com/products/fda-510k-k173785-custom-clear-aligner-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173785, Custom Clear Aligner System, by Derby Dental Laboratory https://foiadocs.com/products/fda-510k-k173784-smylic-invisible-clear-aligners 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173784, Smylic Invisible Clear Aligners, by Smylio, Inc. https://foiadocs.com/products/fda-510k-k180241-orthocaps-twinaligner 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K180241, Orthocaps Twinaligner, by Ortho Caps GmbH https://foiadocs.com/products/fda-510k-k182329-surecure-orthodontic-aligner-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182329, SureCure Orthodontic Aligner System, by Digital Orthodontic Care https://foiadocs.com/products/fda-510k-k190277-provate-vaginal-support 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190277, ProVate Vaginal Support, by Contipi Medical , Ltd. https://foiadocs.com/products/fda-510k-k171328-cneuro-cmri 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171328, cNeuro cMRI, by Combinostics OY https://foiadocs.com/products/fda-510k-k182038-uriscan-10acr-urine-strips-on-the-uriscan-optima-urine-analyzer 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182038, URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer, by Yd Diagnostics Corporation https://foiadocs.com/products/fda-510k-k171521-dus-r-50s-urine-chemistry-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171521, DUS R-50S (Urine Chemistry system), by DFI Co., Ltd. https://foiadocs.com/products/fda-510k-k160062-aution-eleven-semi-automated-urinalysis-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160062, AUTION ELEVEN Semi-Automated Urinalysis System, by Arkray, Inc. https://foiadocs.com/products/fda-510k-k141289-tc-thunderbolt-automated-urine-analyzer-system-and-tc-thunderbolt-urs-10-strips 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141289, TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS, by Teco Diagnostics https://foiadocs.com/products/fda-510k-k181643-smartbag-smartpouch 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K181643, SmartBag (SmartPouch), by 11 Health Technologies Limited https://foiadocs.com/products/fda-510k-k123954-infinity-total-ankle-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123954, INFINITY TOTAL ANKLE SYSTEM, by Wrightmedicaltechnologyinc https://foiadocs.com/products/fda-510k-k181784-spectra-s3-plus 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K181784, Spectra S3 Plus, by Uzinmedicare Co. https://foiadocs.com/products/fda-510k-k162759-kerastatr-gel 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K162759, KeraStat(R) Gel, by Keranetics, LLC https://foiadocs.com/products/fda-510k-k153283-vivosight-dx-topical-oct-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153283, VivoSight Dx Topical OCT System, by Michelson Diagnostics, Ltd. https://foiadocs.com/products/fda-510k-k093520-vivosight-topical-oct-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093520, VIVOSIGHT TOPICAL OCT SYSTEM, by Michelson Diagnostics, Ltd. https://foiadocs.com/products/fda-510k-k163105-emprint-ablation-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K163105, Emprint Ablation System, by Covidien, LLC https://foiadocs.com/products/fda-510k-k150174-emma 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150174, EMMA, by Inrange Systems, Inc. https://foiadocs.com/products/fda-510k-k173372-exactechgps-total-shoulder-application 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173372, ExactechGPS Total Shoulder Application, by Blue Ortho https://foiadocs.com/products/fda-510k-k191100-excelsiusgps-spine-1-1-interbody-module 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191100, ExcelsiusGPS Spine 1.1 Interbody Module, by Globus Medical, Inc. https://foiadocs.com/products/fda-510k-k162891-complete-control-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K162891, Complete Control System, by Coapt, LLC https://foiadocs.com/products/fda-510k-k173571-element-system-with-ibt-electrodes 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173571, Element System with IBT Electrodes, by Infinite Biomedical Technologies, LLC https://foiadocs.com/products/fda-510k-k153229-superbium 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153229, Superbium, by Bios S.R.L. https://foiadocs.com/products/fda-510k-k171277-reprocessed-inquiry-steerable-diagnostic-ep-catheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171277, Reprocessed Inquiry Steerable Diagnostic EP Catheter, by Innovative Health, LLC https://foiadocs.com/products/fda-510k-k062842-twist-drill 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062842, TWIST DRILL, by Walter Lorenz Surgical, Inc. https://foiadocs.com/products/fda-510k-k132167-i-chroma-ifob-with-i-chroma-reader 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132167, I-CHROMA IFOB WITH I-CHROMA READER, by Boditech Med, Inc. https://foiadocs.com/products/fda-510k-k132148-s-health 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132148, S HEALTH, by Samsung Electronics Co., Ltd. https://foiadocs.com/products/fda-510k-k160501-noxilizer-surgical-ruler 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160501, Noxilizer Surgical Ruler, by Noxilizer, Inc. https://foiadocs.com/products/fda-510k-k031373-ixl-diabetes-management-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K031373, IXL DIABETES MANAGEMENT SYSTEM, by Insulet Corp. https://foiadocs.com/products/fda-510k-k191564-progenikine-concentrating-system-25-ml-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191564, Progenikine Concentrating System 25 mL System, by Emcyte Corporation https://foiadocs.com/products/fda-510k-k192656-optimized-positioning-system-ops-insight 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192656, Optimized Positioning System (OPS) Insight, by Corin USA https://foiadocs.com/products/fda-510k-k190548-biomonitor-iii-remote-assistant-iii 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190548, BIOMONITOR III, Remote Assistant III, by Biotronik, Inc. https://foiadocs.com/products/fda-510k-k170848-alzair-allergy-blocker 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K170848, Alzair Allergy Blocker, by Nasaleze International, Ltd. https://foiadocs.com/products/fda-510k-k200240-turbett-instrument-pod 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200240, Turbett Instrument Pod, by Turbett Surgical, Inc. https://foiadocs.com/products/fda-510k-k181295-genesys-spine-ais-c-cervical-stand-alone-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K181295, Genesys Spine AIS-C Cervical Stand-Alone System, by Genesys Spine https://foiadocs.com/products/fda-510k-k191489-genesys-spine-3dp-cervical-interbody-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191489, Genesys Spine 3DP Cervical Interbody System, by Genesys Spine https://foiadocs.com/products/fda-510k-k190917-v-pro-60-a-low-tempurature-strilization-systems-v-pro-s2-low-temperature-sterilization-systems 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190917, V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems, by STERIS Corporation https://foiadocs.com/products/fda-510k-k200948-fitbit-ecg-app 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200948, Fitbit ECG App, by Fitbit, Inc. https://foiadocs.com/products/fda-510k-k171992-sculpsure 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171992, SculpSure, by Cynosure, Inc. https://foiadocs.com/products/fda-510k-k193483-basal-iq-technology 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K193483, Basal-IQ Technology, by Tandem Diabetes Care, Inc. https://foiadocs.com/products/fda-510k-k200467-control-iq-technology 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200467, Control-IQ Technology, by Tandem Diabetes Care, Inc. https://foiadocs.com/products/fda-510k-k201214-t-slim-x2-insulin-pump-with-interoperable-technology 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K201214, t:slim X2 Insulin Pump with Interoperable Technology, by Tandem Diabetes Care, Inc. https://foiadocs.com/products/fda-510k-k172085-photofix-decellularized-bovine-pericardium 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K172085, PhotoFix Decellularized Bovine Pericardium, by Cryolife, Inc. https://foiadocs.com/products/fda-510k-k151638-phenom-17-catheter-phenom-21-catheter-phenom-27-catheter-phenom-plus-catheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151638, Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter, by Cathera, Inc. https://foiadocs.com/products/fda-510k-k182618-sleepimage-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182618, SleepImage System, by Mycardio, LLC Dba Sleepimage. https://foiadocs.com/products/fda-510k-k153473-braemar-telemetry-patch-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153473, Braemar Telemetry Patch System, by Braemar Manufacturing, LLC https://foiadocs.com/products/fda-510k-k171410-epatch 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171410, ePatch, by Braemar Manufacturing, LLC https://foiadocs.com/products/fda-510k-k040139-endobionics-microsyringe-usyringe-infusion-catheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K040139, ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER, by Endobionics, Inc. https://foiadocs.com/products/fda-510k-k131401-blowfish-transbronchial-micro-infusion-catheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131401, BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER, by Mercator Medsystems, Inc. https://foiadocs.com/products/fda-510k-k062752-mercator-microsyringe-ii-infusion-catheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062752, MERCATOR MICROSYRINGE II INFUSION CATHETER, by Mercator Medsystems, Inc. https://foiadocs.com/products/fda-510k-k183370-peramobile-and-perawatch 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K183370, PeraMobile and PeraWatch, by Perahealth, Inc. https://foiadocs.com/products/fda-510k-k200163-ava-fertility-tracker 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200163, Ava Fertility Tracker, by Ava AG https://foiadocs.com/products/fda-510k-k171643-geistlich-bio-gide-shape-geistlich-bio-gide-compressed 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171643, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, by Geistlich Pharma AG https://foiadocs.com/products/fda-510k-k140552-cadwell-spike-and-seizure-detector 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140552, CADWELL SPIKE AND SEIZURE DETECTOR, by Cadwell https://foiadocs.com/products/fda-510k-k151929-persyst-13-p13-eeg-review-and-analysis-software 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151929, PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE, by Persyst Development Corporation https://foiadocs.com/products/fda-510k-k122288-brainsway-deep-tms-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122288, BRAINSWAY DEEP TMS SYSTEM, by Brainsway , Ltd. https://foiadocs.com/products/fda-510k-k200957-brainsway-deep-tms-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200957, Brainsway Deep TMS System, by Brainsway , Ltd. https://foiadocs.com/products/fda-510k-k203086-x-plo2r 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203086, X-PLO2R, by Belluscura, LLC https://foiadocs.com/products/fda-510k-k112478-visi-mobile-monitoring-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K112478, VISI MOBILE MONITORING SYSTEM, by Sotera Wireless, Inc. https://foiadocs.com/products/fda-510k-k130709-visi-mobile-monitoring-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130709, VISI MOBILE MONITORING SYSTEM, by Sotera Wireless, Inc. https://foiadocs.com/products/fda-510k-k183453-vs3-ir 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K183453, VS3-IR, by Medtronic https://foiadocs.com/products/fda-510k-k142556-flexible-video-uretero-choledochoscope-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142556, Flexible Video-Uretero-Choledochoscope System, by KARL STORZ Endoscopy-America, Inc. https://foiadocs.com/products/fda-510k-k161654-nuface-gel-primer 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161654, NuFACE Gel Primer, by Carol Cole Company https://foiadocs.com/products/fda-510k-k162784-silkn-hst 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K162784, Silk'n HST, by Home Skinovations , Ltd. https://foiadocs.com/products/fda-510k-k182774-stop-u-packed-black-usa-stop-u-packed-white-usa 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182774, STOP U (Packed Black USA), STOP U (Packed White USA), by Pollogen, Ltd. https://foiadocs.com/products/fda-510k-k163069-olympus-small-intestinal-capsule-endoscope-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K163069, OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM, by Olympus Medical Systems Corp. https://foiadocs.com/products/fda-510k-k190948-magic-clear-aligners 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190948, Magic Clear Aligners, by Voodoo Manufacturing, Inc. https://foiadocs.com/products/fda-510k-k203550-activsight-intraoperative-imaging-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203550, ActivSight Intraoperative Imaging System, by Activ Surgical, Inc. https://foiadocs.com/products/fda-510k-k925111-house-infrared-video-electronystagmograph-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K925111, HOUSE INFRARED/VIDEO ELECTRONYSTAGMOGRAPH SYSTEM, by Eye Dynamics, Inc. https://foiadocs.com/products/fda-510k-k021362-lifeport-kidney-perfusion-transporter-ktr 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K021362, LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR), by Organ Recovery Systems, Inc. https://foiadocs.com/products/fda-510k-k896975-cardiac-cooling-jacket-30-reduced-model-cj-220 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K896975, CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220, by Daily Medical Products, Inc. https://foiadocs.com/products/fda-510k-k781990-cardiac-insulation-pad 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K781990, CARDIAC INSULATION PAD, by Shiley, Inc. https://foiadocs.com/products/fda-510k-k874927-pti-heart-chilltm-cardiac-insulating-jacket 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K874927, PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET, by Pioneering Technologies, Inc. https://foiadocs.com/products/fda-510k-k142587-vertical-expandable-prosthetic-titanium-rib 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142587, Vertical Expandable Prosthetic Titanium Rib, by Depuy Synthes Spine, Inc. https://foiadocs.com/products/fda-510k-k180337-europa-pedicle-screw-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K180337, EUROPA Pedicle Screw System, by MiRus, LLC https://foiadocs.com/products/fda-510k-k143120-orthopulse 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143120, OrthoPulse, by Biolux Research , Ltd. https://foiadocs.com/products/fda-510k-k210269-powerdot-pd-01mt2-muscle-stimulator 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K210269, PowerDot PD-01MT2 Muscle Stimulator, by Smartmissimo Technologies Pte, Ltd. https://foiadocs.com/products/fda-510k-k192109-koala 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192109, KOALA, by Ib Lab GmbH https://foiadocs.com/products/fda-510k-k202487-healthjoint 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K202487, HealthJOINT, by Zebra Medical Vision, Ltd. https://foiadocs.com/products/fda-510k-k193417-fracturedetect-fx 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K193417, FractureDetect (FX), by Imagen Technologies, Inc. https://foiadocs.com/products/fda-510k-k181751-hemocue-hb-801-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K181751, HemoCue Hb 801 System, by Hemocue AB https://foiadocs.com/products/fda-510k-k945120-thymatron-2000-electroconvulsive-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K945120, THYMATRON 2000 ELECTROCONVULSIVE SYSTEM, by Somatics, Inc. https://foiadocs.com/products/fda-510k-k843923-thymatron 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K843923, THYMATRON, by Somatics, Inc. https://foiadocs.com/products/fda-510k-k150852-sic-8000 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150852, SIC 8000, by Cosmo Technologies, Ltd. https://foiadocs.com/products/fda-510k-k200071-blue-beacon-submucosal-injectable-solution 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200071, Blue Beacon Submucosal Injectable Solution, by Micro-Tech (Nanjing) Co., Ltd. https://foiadocs.com/products/fda-510k-k191923-everlift-submucosal-lifting-agent 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191923, EverLift Submucosal Lifting Agent, by Gi Supply https://foiadocs.com/products/fda-510k-k191254-endoclot 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191254, EndoClot, by Endoclot Plus Co., Ltd. https://foiadocs.com/products/fda-510k-k180068-orise-gel 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K180068, ORISE Gel, by Boston Scientific https://foiadocs.com/products/fda-510k-k200500-molekule-air-pro-rx 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200500, Molekule Air Pro RX, by Molekule, Inc. https://foiadocs.com/products/fda-510k-k161447-hydroset-xt 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161447, HydroSet XT, by Orthovita, Inc. https://foiadocs.com/products/fda-510k-k120368-capstone-control-spinal-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120368, CAPSTONE CONTROL SPINAL SYSTEM, by Medtronic Sofamor Danek USA, Inc. https://foiadocs.com/products/fda-510k-k192863-mondrian-lumbar-interbody-fusion-cage-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192863, MONDRIAN Lumbar Interbody Fusion Cage System, by Ctl Medical Corporation https://foiadocs.com/products/fda-510k-k202184-practical-navigation-surgical-guidance-system-pnsgs 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K202184, Practical Navigation Surgical Guidance System (PNSGS), by Practical Navigation, LLC https://foiadocs.com/products/fda-510k-k162524-azur-cx-detachable-18-peripheral-coil-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K162524, AZUR CX Detachable 18 Peripheral Coil System, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k163154-traxcess-7-mini-xsoft-guidewire 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K163154, Traxcess 7 Mini XSoft Guidewire, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k191680-azur-vascular-plug 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191680, AZUR Vascular Plug, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k062061-urassist 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062061, URASSIST, by Preferred Medical Devices, Inc. https://foiadocs.com/products/fda-510k-k080863-traxcess-0-014-hydrophilic-guidewire 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080863, TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k090168-azur-detactable-18-models-45-480305-45-480310-45-480405-44-480415 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K090168, AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k083343-headway-17-microcatheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K083343, HEADWAY 17 MICROCATHETER, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k090357-hydroframe-hes 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K090357, HYDROFRAME (HES), by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k090891-microplex-coil-system-cosmos 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K090891, MICROPLEX COIL SYSTEM-COSMOS, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k091882-azur-peripheral-hydrocoil-endovascular-embolization-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K091882, AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k093160-headway-21-microcatheter-model-mc212150s 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093160, HEADWAY 21 MICROCATHETER, MODEL: MC212150S, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k093397-traxcess-14ex-guidewire-and-traxcess-docking-wire 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093397, TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k093647-traxcess-docking-wire 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093647, TRAXCESS DOCKING WIRE, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k093919-microplex-coil-system-cosmos-model-100933cssr-v-101036cssr-v-101141cssr-v-101245cssr-v 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093919, MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k101542-headway-17-advanced-microcatheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K101542, HEADWAY 17 ADVANCED MICROCATHETER, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k111307-azur-detachable-35-platinum-coil-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K111307, AZUR DETACHABLE 35 PLATINUM COIL SYSTEM, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k120917-headway-duo-microcatheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K120917, HEADWAY DUO MICROCATHETER, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k122543-azur-pure-peripheral-coil-system-pushable-18-azur-pure-peripheral-coil-system-pushable-35 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122543, AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k123384-azur-cx-detachable-18 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123384, AZUR CX DETACHABLE 18, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k130577-azur-pushable-18-35-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130577, AZUR PUSHABLE 18 & 35 SYSTEM, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k133626-azur-pure-peripheral-coil-system-pushable-35 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133626, AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k153053-traxcess-pro-14-guidewire 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153053, Traxcess Pro 14 Guidewire, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k200077-biomin-restore-plus 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200077, BioMin Restore Plus, by Dr. Collins, Inc. https://foiadocs.com/products/fda-510k-k161298-shenda-sinuscope 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161298, ShenDa Sinuscope, by Shenyang Shenda Endoscope Co., Ltd. https://foiadocs.com/products/fda-510k-k193376-visalis-v500-visalis-s500 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K193376, Visalis V500, Visalis S500, by Carl Zeiss Meditec, AG https://foiadocs.com/products/fda-510k-k013086-wet-light-personal-moisturizer 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K013086, WET LIGHT PERSONAL MOISTURIZER, by Trigg Laboratories, Inc. https://foiadocs.com/products/fda-510k-k073707-ge-datex-ohmeda-aisys 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K073707, GE DATEX-OHMEDA AISYS, by Datex-Ohmeda, Inc. https://foiadocs.com/products/fda-510k-k092148-hamilton-c2 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092148, HAMILTON-C2, by Hamilton Medical AG https://foiadocs.com/products/fda-510k-k902114-cuff-mate-2-endotracheal-cuff-inflator-monitor 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K902114, CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR, by Diemolding Corp. https://foiadocs.com/products/fda-510k-k190010-penumbra-system-reperfusion-catheter-jet-7 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190010, Penumbra System Reperfusion Catheter JET 7, by Penumbra, Inc. https://foiadocs.com/products/fda-510k-k173761-penumbra-system-reperfusion-catheter-jet-7 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173761, Penumbra System Reperfusion Catheter JET 7, by Penumbra, Inc. https://foiadocs.com/products/fda-510k-k191828-vathin-video-bronchoscope-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191828, Vathin Video Bronchoscope System, by Hunan Vathin Medical Instrument Co., Ltd. https://foiadocs.com/products/fda-510k-k961901-bone-marrow-collection-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K961901, BONE & MARROW COLLECTION SYSTEM, by Biomedical Ent., Inc. https://foiadocs.com/products/fda-510k-k971782-bone-and-marrow-collection-system-kit 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K971782, BONE AND MARROW COLLECTION SYSTEM KIT, by Biomedical Ent., Inc. https://foiadocs.com/products/fda-510k-k200483-spyglass-discover-digital-catheter-spyglass-discover-digital-controller 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200483, SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller, by Boston Scientific Corporation https://foiadocs.com/products/fda-510k-k111426-euclid-tm-tier-1-gw-access-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K111426, EUCLID (TM) TIER 1-GW ACCESS SYSTEM, by Houston Medical Robotics https://foiadocs.com/products/fda-510k-k203737-spark-clear-aligner-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203737, Spark Clear Aligner System, by Ormco Corporation https://foiadocs.com/products/fda-510k-k180045-omnipod-dash-insulin-management-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K180045, Omnipod DASH Insulin Management System, by Insulet Corporation https://foiadocs.com/products/fda-510k-k170008-osteo-site-bone-biopsy-needle-osteo-site-bone-biopsy-needle-set 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K170008, Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set, by Cook Incorporated https://foiadocs.com/products/fda-510k-k171011-pentax-medical-vivideo-ent-videoscope-solution 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171011, PENTAX Medical VIVIDEO ENT Videoscope Solution, by Pentax Medical https://foiadocs.com/products/fda-510k-k173244-superdimension-navigation-system-v7-2 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173244, superDimension Navigation System V7.2, by Covidien, LLC https://foiadocs.com/products/fda-510k-k132393-cercom-ii-cement 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132393, CERCOM II CEMENT, by Denali Corporation https://foiadocs.com/products/fda-510k-k201308-axonpen-axonmonitor-axonbox-tablet 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K201308, Axonpen, Axonmonitor, Axonbox, Tablet, by Clearmind Biomedical https://foiadocs.com/products/fda-510k-k202464-vital-sign-monitoring-sensor-model-xk300 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K202464, Vital Sign Monitoring Sensor (Model :XK300), by Xandar Kardian, Inc. https://foiadocs.com/products/fda-510k-k092590-pds-plates 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092590, PDS PLATES, by ETHICON, Inc. https://foiadocs.com/products/fda-510k-k132920-spirox-inex-device 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132920, SPIROX INEX DEVICE, by Spirox, Inc. https://foiadocs.com/products/fda-510k-k060389-confidose-im-auto-injector 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K060389, CONFIDOSE IM AUTO-INJECTOR, by Pharma-Pen, Inc. https://foiadocs.com/products/fda-510k-k203629-idx-dr 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203629, IDx-DR, by Digital Diagnostics, Inc. https://foiadocs.com/products/fda-510k-k140167-renaissance-x-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140167, RENAISSANCE X SYSTEM, by Mazor Robotics , Ltd. https://foiadocs.com/products/fda-510k-k193348-blood-pressure-monitor 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K193348, Blood Pressure Monitor, by Shenzhen Viatom Technology Co., Ltd. https://foiadocs.com/products/fda-510k-k202072-mindseye-expandable-port 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K202072, MindsEye Expandable Port, by Minnetronix Neuro, Inc. https://foiadocs.com/products/fda-510k-k210484-linq-ii-insertable-cardiac-monitor-zelda-ai-ecg-classification-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K210484, LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System, by Medtronic, Inc. https://foiadocs.com/products/fda-510k-k211190-3m-clarity-aligners-3m-clarity-aligners-force-3m-clarity-aligners-flex 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K211190, 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex), by 3M Company, Unitek Orthodontic Products https://foiadocs.com/products/fda-510k-k110823-prismaflex 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110823, PRISMAFLEX, by Gambro Renal Products, Inc. https://foiadocs.com/products/fda-510k-k133807-mars-monitor-itc-us-mars-treatment-kit-type-1116-1-x-mars-us-prismaflex-control-unit 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133807, MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT, by Gambro Renal Products, Inc. https://foiadocs.com/products/fda-510k-k210544-medtronic-extended-infusion-set 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K210544, Medtronic Extended infusion set, by Unomedical A/S https://foiadocs.com/products/fda-510k-k190675-dimension-exl-high-sensitivity-troponin-i-tnih-assay 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190675, Dimension EXL High-Sensitivity Troponin I (TNIH) Assay, by Siemens Healthcare Diagnostics, Inc. https://foiadocs.com/products/fda-510k-k191595-architect-stat-high-sensitivity-troponin-i 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191595, ARCHITECT STAT High Sensitivity Troponin-I, by Abbott Laboratories Diagnostics Division https://foiadocs.com/products/fda-510k-k003227-bio-absorbable-corkscrew-model-ar-1920b 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K003227, BIO-ABSORBABLE CORKSCREW MODEL AR-1920B, by Arthrex, Inc. https://foiadocs.com/products/fda-510k-k100947-finesse-personal-insulin-delivery-patch-model-fg-2000 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K100947, FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000, by Calibra Medical, Inc. https://foiadocs.com/products/fda-510k-k940957-hemochron-verigy-system-factor-vi-qualify-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K940957, HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM, by International Technidyne Corp. https://foiadocs.com/products/fda-510k-k210176-flowsaver-blood-filter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K210176, FlowSaver Blood Filter, by Inari Medical https://foiadocs.com/products/fda-510k-k923815-total-protective-breatheable-surgical-gowns 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K923815, TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS, by Laivan Corp. https://foiadocs.com/products/fda-510k-k063602-autopulse-resuscitation-system-model100 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K063602, AUTOPULSE RESUSCITATION SYSTEM MODEL100, by Zoll Circulation https://foiadocs.com/products/fda-510k-k040453-autopulse-resuscitation-system-model-100 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K040453, AUTOPULSE RESUSCITATION SYSTEM, MODEL 100, by Revivant Corp. https://foiadocs.com/products/fda-510k-k071168-the-portable-ansiscope 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K071168, THE PORTABLE ANSISCOPE, by Dyansys, Inc. https://foiadocs.com/products/1007fdak240726-k211786 2026-08-09T23:19:55-05:00 daily https://foiadocs.com/products/fda-drug-approval-n017381-silvadene 2026-08-09T23:19:55-05:00 daily https://foiadocs.com/products/fda-510k-k133593-t-slim-insulin-delivery-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133593, T:SLIM INSULIN DELIVERY SYSTEM, by Tandem Diabetes Care, Inc. https://foiadocs.com/products/fda-510k-k130041-sheathes-sterile-ultrasound-gel 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130041, SHEATHES STERILE ULTRASOUND GEL, by Sheathing Technologies, Inc. https://foiadocs.com/products/fda-510k-k143233-mitsar-eeg 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143233, Mitsar-EEG, by Mitsar Co., Ltd. https://foiadocs.com/products/fda-510k-k121197-bodyguardian-system-bodyguardian-control-unit-bodyguardian-connect 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121197, BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT, by Preventice, Inc. https://foiadocs.com/products/fda-510k-k993455-flipper-detachable-embolization-coil 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K993455, FLIPPER DETACHABLE EMBOLIZATION COIL, by Cook, Inc. https://foiadocs.com/products/fda-510k-k152402-irts-thermal-imaging-probe-tip-irts-patient-monitoring-unit-pmu-irts-patient-interface-unit-piu 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152402, IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU), by Securus,Inc https://foiadocs.com/products/fda-510k-k094039-hyalo-gyn 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K094039, HYALO GYN, by Fidia Farmaceutici S.P.A. https://foiadocs.com/products/fda-510k-k121161-empty-eva-solution-container-empty-eva-dual-chamber-solution-container 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121161, EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER, by Acta Medical, LLC https://foiadocs.com/products/fda-510k-k143499-ecligner 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143499, eCligner, by Eclear International Co., Ltd. https://foiadocs.com/products/fda-510k-k150078-powerdotr-pd-01-muscle-stimulator-with-powerdotr-mobile-application 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150078, PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application), by Smartmissimo Technologies Pte, Ltd. https://foiadocs.com/products/fda-510k-k160339-cardinal-health-isolation-gown 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160339, Cardinal Health Isolation Gown, by Cardinal Health200, LLC https://foiadocs.com/products/fda-510k-k160887-cook-intraosseous-infusion-needles 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160887, Cook Intraosseous Infusion Needles, by Cook Incorporated https://foiadocs.com/products/fda-510k-k982532-parietex 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K982532, PARIETEX, by Cogent https://foiadocs.com/products/fda-510k-k915774-prolene-polypropylene-mesh-plug-w-onlay-patch 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K915774, PROLENE POLYPROPYLENE MESH PLUG W/ ONLAY PATCH, by ETHICON, Inc. https://foiadocs.com/products/fda-510k-k984220-modification-of-prolene-polypropylene-hernia-system-nonabsorbable-synthetic-surgical-mesh 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K984220, MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH, by ETHICON, Inc. https://foiadocs.com/products/fda-510k-k161090-cranial-psi 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161090, Cranial PSI, by Ossdsign AB https://foiadocs.com/products/fda-510k-k081776-continuous-cardiac-ouput-monitor-truccom 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K081776, CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM, by Omega Critical Care Limited https://foiadocs.com/products/fda-510k-k061733-angiodynamics-soft-vu-and-mariner-hydrophilic-coated-angiographic-catheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061733, ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER, by AngioDynamics, Inc. https://foiadocs.com/products/fda-510k-k913869-rf-opaque-blanket-for-magnetom-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K913869, RF-OPAQUE BLANKET FOR MAGNETOM SYSTEM, by Siemens Medical Solutions USA, Inc. https://foiadocs.com/products/fda-510k-k050124-porous-coated-acetabular-components 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K050124, POROUS COATED ACETABULAR COMPONENTS, by Biomet, Inc. https://foiadocs.com/products/fda-510k-k921277-ranawat-burstein-total-hip-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K921277, RANAWAT/BURSTEIN TOTAL HIP SYSTEM, by Biomet, Inc. https://foiadocs.com/products/fda-510k-k931393-bebig-plaques-rum101-rum114 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K931393, BEBIG PLAQUES RUM101-RUM114, by Bebig, Inc. https://foiadocs.com/products/fda-510k-k090242-gamma-bsm-beta-bsm 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K090242, GAMMA-BSM, BETA-BSM, by Etex Corp. https://foiadocs.com/products/fda-510k-k132368-vapor-ceramic-bracket 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132368, VAPOR CERAMIC BRACKET, by Orthodontic Design and Production, Inc. https://foiadocs.com/products/fda-510k-k930748-sigma-mp-multiplace-hyperbaric-chamber 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K930748, SIGMA MP MULTIPLACE HYPERBARIC CHAMBER, by Perry Baromedical Services https://foiadocs.com/products/fda-510k-k141453-ilumien-optis-dragonfly-optis-imaging-catheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141453, ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER, by Lightlab Imaging, Inc. https://foiadocs.com/products/fda-510k-k052697-heparin-platelet-factor-4-antibody-serum-panel 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K052697, HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL, by Akers Biosciences, Inc. https://foiadocs.com/products/fda-510k-k102965-celox-trauma-gauze-ag-celox-hemostatic-antibacterial-trauma-gauze-omni-stat-trauma-gauze-ag-omni-stat-hemostatic-anti 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K102965, CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI, by Medtrade Products , Ltd. https://foiadocs.com/products/fda-510k-k160749-crit-line-iii-blood-chamber-ii 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160749, CRIT-LINE III Blood Chamber II, by Fresenius Medical Care Renal Therapies Group, LLC https://foiadocs.com/products/fda-510k-k141997-crit-line-iv-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141997, CRIT-LINE IV SYSTEM, by Fresenius Medical Care https://foiadocs.com/products/fda-510k-k152953-crit-line-clip-clic-blood-chamber 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152953, CRIT-LINE CLIP (CLIC) BLOOD CHAMBER, by Fresenius Medical Care North America https://foiadocs.com/products/fda-510k-k180820-tono-vue-non-contact-tonometer 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K180820, Tono Vue Non-Contact Tonometer, by Crystalvue Medical Corporation https://foiadocs.com/products/fda-510k-k180259-sterile-hypodermic-needle-for-single-use 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K180259, Sterile Hypodermic Needle for Single Use, by Jiangsu Shenli Medical Production Co., Ltd. https://foiadocs.com/products/fda-510k-k172938-disposable-sterile-needle 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K172938, Disposable Sterile Needle, by Jiangsu Caina Medical Co.,Ltd https://foiadocs.com/products/fda-510k-k143067-carnation-ambulatory-monitor 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143067, Carnation Ambulatory Monitor, by Bardy Diagnostics, Inc. https://foiadocs.com/products/fda-510k-k171933-asahi-ptca-guide-wires-asahi-corsair-microcatheter-asahi-corsair-pro-microcatheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171933, ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter, by Asahi Intecc Co., Ltd. https://foiadocs.com/products/fda-510k-k142065-turnpike-catheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142065, TURNPIKE CATHETER, by Vascular Solutions, Inc. https://foiadocs.com/products/fda-510k-k161126-asahi-corsair-pro 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161126, ASAHI Corsair Pro, by Asahi Intecc Co., Ltd. https://foiadocs.com/products/fda-510k-k163549-clottriever-thrombectomy-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K163549, ClotTriever Thrombectomy System, by Inari Medical, Inc. https://foiadocs.com/products/fda-510k-k082474-pmt-subdural-cortical-electrodes 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082474, PMT SUBDURAL CORTICAL ELECTRODES, by Pmt Corp. https://foiadocs.com/products/fda-510k-k152547-dnap-electrode 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152547, DNAP Electrode, by Ad-Tech Medical Instrument Corporation https://foiadocs.com/products/fda-510k-k171581-neuro-omega-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171581, Neuro Omega System, by Alpha Omega Engineering , Ltd. https://foiadocs.com/products/fda-510k-k161772-ffrct 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161772, FFRct, by HeartFlow, Inc. https://foiadocs.com/products/fda-510k-k152733-ffrct 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152733, FFRct, by HeartFlow, Inc. https://foiadocs.com/products/fda-510k-k112342-flexi-seal-signal-fecal-management-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K112342, FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM, by Convatec, Inc. https://foiadocs.com/products/fda-510k-k093857-c7-xr-imaging-system-with-c7-dragonfly-imaging-catheter-and-disposable-accessories 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093857, C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES, by Lightlab Imaging, Inc. https://foiadocs.com/products/fda-510k-k163451-action-trackstander-models-tr1816-tr1820-tr2016-and-tr2020 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K163451, Action Trackstander models TR1816, TR1820, TR2016, and TR2020, by Action Manufacturing, Inc. https://foiadocs.com/products/fda-510k-k151911-workmate-claris-system-workmate-claris-system-display-plus 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151911, WorkMate Claris System, WorkMate Claris System Display Plus, by St Jude Medical https://foiadocs.com/products/fda-510k-k191660-carto-3-ep-navigation-system-version-7-1-and-accessories 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191660, CARTO 3 EP Navigation System, Version 7.1 and Accessories, by Biosense Webster, Inc. https://foiadocs.com/products/fda-510k-k190180-cusa-clarity-ultrasonic-surgical-aspirator-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190180, CUSA Clarity Ultrasonic Surgical Aspirator System, by Integra LifeSciences Corporation https://foiadocs.com/products/fda-510k-k182848-rosa-one-spine-application 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182848, ROSA ONE Spine application, by Medtech S.A https://foiadocs.com/products/fda-510k-k163328-planmed-clarity 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K163328, Planmed Clarity, by Planmed OY https://foiadocs.com/products/fda-510k-k172593-xcellistem-wound-powder 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K172593, XCelliStem Wound Powder, by Stemsys https://foiadocs.com/products/fda-510k-k983119-entero-test-hp-model-102-01 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K983119, ENTERO-TEST HP, MODEL #102-01, by Hdc Corp. https://foiadocs.com/products/fda-510k-k040163-microvascular-anastomotic-device 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K040163, MICROVASCULAR ANASTOMOTIC DEVICE, by Synovis Micro Companies Alliance, Inc. https://foiadocs.com/products/fda-510k-k001337-daniels-sharpsmart-reusable-sharps-container 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K001337, DANIELS SHARPSMART REUSABLE SHARPS CONTAINER, by The Daniels Corp. https://foiadocs.com/products/fda-510k-k051647-fortaderm-antimicrobial-wound-dressing 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K051647, FORTADERM ANTIMICROBIAL WOUND DRESSING, by Organogenesis, Inc. https://foiadocs.com/products/fda-510k-k131234-lungpoint-tools-lungpoint-sheath-lungpoint-dilation-balloon 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131234, LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON), by Broncus Medical, Inc. https://foiadocs.com/products/fda-510k-k160707-customizedbone-service 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160707, CustomizedBone Service, by Fin-Ceramica Faenza S.P.A. https://foiadocs.com/products/fda-510k-k162594-craniomaxillofacial-distraction-system-cmfd 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K162594, Craniomaxillofacial Distraction System (CMFD), by Synthes USA Products, LLC https://foiadocs.com/products/fda-510k-k161893-neuromonitoring-kit 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161893, Neuromonitoring Kit, by SI-BONE, Inc. https://foiadocs.com/products/fda-510k-k101128-biofriend-biomask-surgical-facemask-models-universal-bf-200-2001-and-premium-bf-200-3013 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K101128, BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013, by Filligent Limited https://foiadocs.com/products/fda-510k-k171239-tula-tube-delivery-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171239, TULA Tube Delivery System, by Tusker Medical https://foiadocs.com/products/fda-510k-k162131-exspiron-1xi 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K162131, ExSpiron 1Xi, by Respiratory Motion, Inc. https://foiadocs.com/products/fda-510k-k161330-pour-acrylic 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161330, Pour Acrylic, by Dentsply Sirona https://foiadocs.com/products/fda-510k-k861985-3m-brand-microvascular-anastomotic-coupler-27xx 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K861985, 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX), by 3M Company https://foiadocs.com/products/fda-510k-k102996-medivators-advantage-plus-endoscope-reprocessor 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K102996, MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR, by Medivators Reprocessing Systems https://foiadocs.com/products/fda-510k-k192854-mammoscreen 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192854, MammoScreen, by Therapixel https://foiadocs.com/products/fda-510k-k160252-omnipod-insulin-management-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160252, OmniPod Insulin Management System, by Insulet Corporation https://foiadocs.com/products/fda-510k-k172955-lungvision-tool 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K172955, LungVision Tool, by Bodyvision Medical , Ltd. https://foiadocs.com/products/fda-510k-k023232-splatrfree-swangle-360-disposable-prophylaxis-angle 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K023232, SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE, by Smartpractice https://foiadocs.com/products/fda-510k-k121604-anospec-disposable-ansoscope-with-light 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121604, ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT, by Obp Corporation https://foiadocs.com/products/fda-510k-k183195-vivo 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K183195, VIVO, by Catheter Precision, Inc. https://foiadocs.com/products/fda-510k-k193559-nextar-tka-platform 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K193559, NextAR TKA Platform, by Medacta Inernational SA https://foiadocs.com/products/fda-510k-k142399-dualcap-iv-pole-stripsdisinfectant-caps-for-male-luers 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142399, DualCap IV Pole Strips(Disinfectant Caps for Male Luers), by Catheter Connections, Inc. https://foiadocs.com/products/fda-510k-k030456-vasc-alert 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K030456, VASC-ALERT, by Vasc-Alert, LLC https://foiadocs.com/products/fda-510k-k042566-vasc-alert 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042566, VASC-ALERT, by Vasc-Alert, Inc. https://foiadocs.com/products/fda-510k-k192105-innonix-antiviral-childs-face-mask 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192105, Innonix Antiviral Child's Face Mask, by Innonix Technologies Limited https://foiadocs.com/products/fda-510k-k200684-gastroduodenal-ftrd-set 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200684, gastroduodenal FTRD Set, by Ovesco Endoscopy AG https://foiadocs.com/products/fda-510k-k180854-voyager-trajectory-array-guide-v-tag 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K180854, Voyager Trajectory Array Guide (V-TAG), by Voyager Therapeutics, Inc. https://foiadocs.com/products/fda-510k-k121976-aesculap-histoacryl-flexible-topical-skin-adhesive 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121976, AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE, by Aesculap, Inc. https://foiadocs.com/products/fda-510k-k161112-karl-storz-flexible-video-neuro-endoscope-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161112, KARL STORZ Flexible Video-Neuro-Endoscope System, by KARL STORZ Endoscopy-America, Inc. https://foiadocs.com/products/fda-510k-k163118-flex-microwave-ablation-system-and-accessories 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K163118, FLEX Microwave Ablation System and Accessories, by Neuwave Medical, Inc. https://foiadocs.com/products/fda-510k-k173756-certus-140-2-45ghz-ablation-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173756, Certus 140 2.45GHz Ablation System, by Neuwave Medical, Inc. https://foiadocs.com/products/fda-510k-k182265-codman-certas-plus-programmable-valve 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182265, CodMan Certas Plus Programmable Valve, by Integra Lifesciences Corp. https://foiadocs.com/products/fda-510k-k191274-bonalive-granules 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191274, BonAlive Granules, by Bonalive Biomaterials, Ltd. https://foiadocs.com/products/fda-510k-k191340-cortrak-2-equilateral-enteral-access-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191340, CORTRAK* 2 Equilateral Enteral Access System, by Avanos Medical, Inc. https://foiadocs.com/products/fda-510k-k973844-gastric-and-rectal-catheters 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K973844, GASTRIC AND RECTAL CATHETERS, by G & J Electronics, Inc. https://foiadocs.com/products/fda-510k-k183206-dexcom-g6-continuous-glucose-monitoring-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K183206, Dexcom G6 Continuous Glucose Monitoring System, by Dexcom, Inc. https://foiadocs.com/products/fda-510k-k191323-carescape-b850 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191323, Carescape B850, by GE Healthcare Finland Oy https://foiadocs.com/products/fda-510k-k161463-surecliptm-repositionable-hemostasis-clip 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161463, SureClip(TM) Repositionable Hemostasis Clip, by Micro-Tech (Nanjing) Co., Ltd. https://foiadocs.com/products/fda-510k-k182967-visor-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182967, Visor System, by Cerebrotech Medical Systems, Inc. https://foiadocs.com/products/fda-510k-k190667-sonopet-iq-sterilization-tray 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190667, Sonopet iQ Sterilization Tray, by Paragon Medical https://foiadocs.com/products/fda-510k-k191606-renovocath 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191606, RenovoCath, by Renovorx, Inc. https://foiadocs.com/products/fda-510k-k110225-angiodynamics-inc-venacure-1470-laser 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110225, ANGIODYNAMICS, INC. VENACURE 1470 LASER, by AngioDynamics, Inc. https://foiadocs.com/products/fda-510k-k051996-diomed-delta-15-model-delta-15-diomed-delta-30-model-delta-30 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K051996, DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30, by Diomed, Ltd. https://foiadocs.com/products/fda-510k-k130798-pre-formed-guidewires 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130798, PRE-FORMED GUIDEWIRES, by Lake Region Medical, Inc. https://foiadocs.com/products/fda-510k-k201301-x100-with-full-field-peripheral-blood-smear-pbs-application 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K201301, X100 with Full Field Peripheral Blood Smear (PBS) Application, by Scopio Labs , Ltd. https://foiadocs.com/products/fda-510k-k192380-st-aia-pack-bnp 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192380, ST AIA-PACK BNP, by Fujirebio Diagnostics,Inc. https://foiadocs.com/products/fda-510k-k081050-parietex-progrip-mesh 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K081050, PARIETEX PROGRIP MESH, by Sofradim Production https://foiadocs.com/products/fda-510k-k101519-parietex-plug-and-patch 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K101519, PARIETEX PLUG AND PATCH, by Sofradim Production https://foiadocs.com/products/fda-510k-k110816-parietex-optimized-composite-mesh-pco-osx-references 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110816, PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES), by Sofradim Production https://foiadocs.com/products/fda-510k-k090858-parietex-monofilament-polyester-mesh 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K090858, PARIETEX MONOFILAMENT POLYESTER MESH, by Sofradim Production https://foiadocs.com/products/fda-510k-k192287-transpara 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192287, Transpara, by Screenpoint Medical B.V. https://foiadocs.com/products/fda-510k-k050187-parietex-composite-pco-os-and-pco-ob-meshes 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K050187, PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES, by Sofradim Production https://foiadocs.com/products/fda-510k-k103682-parietex-progrip 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K103682, PARIETEX PROGRIP, by Sofradim Production https://foiadocs.com/products/fda-510k-k071629-parietex-polyester-mesh-with-introducer 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K071629, PARIETEX POLYESTER MESH WITH INTRODUCER, by Sofradim Production https://foiadocs.com/products/fda-510k-k110815-parietex-optimized-compostie-mesh 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110815, PARIETEX OPTIMIZED COMPOSTIE MESH, by Sofradim Production https://foiadocs.com/products/fda-510k-k180192-emprint-ablation-visualization-application 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K180192, Emprint Ablation Visualization Application, by Covidien, LLC https://foiadocs.com/products/fda-510k-k150669-neoss-tibase-neoss-cocr-abutments-mono-and-multi 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150669, Neoss TiBase, Neoss CoCr Abutments (Mono and Multi), by Neoss, Ltd. https://foiadocs.com/products/fda-510k-k203782-nanox-cart-x-ray-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203782, Nanox Cart X-ray System, by Nano-X Imaging , Ltd. https://foiadocs.com/products/fda-510k-k221537-nightwear-aligners 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K221537, Nightwear Aligners, by Smylio, Inc. https://foiadocs.com/products/fda-510k-k033548-roche-diagnostics-urisys-1100-urine-analyzer 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K033548, ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER, by Roche Diagnostics Corp. https://foiadocs.com/products/fda-510k-k934261-erbokryo-ca-cryosurgical-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K934261, ERBOKRYO CA CRYOSURGICAL SYSTEM, by Erbe Elektromedizin GmbH https://foiadocs.com/products/fda-510k-k051509-erbe-erbokryo-ca-cryosurgical-unit-accessories 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K051509, ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES, by Erbe USA, Inc. https://foiadocs.com/products/fda-510k-k212519-overjet-caries-assist 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K212519, Overjet Caries Assist, by Overjet, Inc. https://foiadocs.com/products/fda-510k-k210187-overjet-dental-assist 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K210187, Overjet Dental Assist, by Overjet, Inc. https://foiadocs.com/products/fda-510k-k220454-vivally-system-wearable-non-invasive-neuromodulation-system-and-mobile-application 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K220454, Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application, by Avation Medical, Inc. https://foiadocs.com/products/fda-510k-k192162-neurovention-cranial-fixation-system-nucrani-plates-ktc-burr-hole-cover-dc-plate 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192162, NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate, by Neurovention, LLC https://foiadocs.com/products/fda-510k-k140941-progrip-self-gripping-polypropylene-mesh-parietene-flat-sheet-mesh 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140941, PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH, by Sofradim Production https://foiadocs.com/products/fda-510k-k143386-progrip-laparoscopic-self-fixating-mesh 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143386, Progrip Laparoscopic Self-Fixating Mesh, by Sofradim Production https://foiadocs.com/products/fda-510k-k771708-worrell-patella 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K771708, WORRELL PATELLA, by Depuy, Inc. https://foiadocs.com/products/fda-510k-k800800-patellar-component-for-lubinus-patellar 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K800800, PATELLAR COMPONENT FOR LUBINUS PATELLAR, by Waldemar Link GmbH & Co. KG https://foiadocs.com/products/fda-510k-k790582-intravascular-administration-set 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K790582, INTRAVASCULAR ADMINISTRATION SET, by Y https://foiadocs.com/products/fda-510k-k221614-tytocare-lung-sounds-analyzer 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K221614, TytoCare Lung Sounds Analyzer, by Tyto Care , Ltd. https://foiadocs.com/products/fda-510k-k210099-meticuly-patient-specific-titanium-mesh-implant 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K210099, Meticuly Patient-Specific Titanium Mesh Implant, by Meticuly Co., Ltd. https://foiadocs.com/products/fda-510k-k904774-inglat-o-ball 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K904774, INGLAT-O-BALL, by Milex Products, Inc. https://foiadocs.com/products/fda-510k-k210541-ulrichinject-ct-motion 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K210541, ulrichINJECT CT motion, by Ulrich GmbH & Co. KG https://foiadocs.com/products/fda-510k-k221303-neuspera-nuity-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K221303, Neuspera Nuity System, by Neuspera Medical, Inc. https://foiadocs.com/products/fda-510k-k221131-tasso 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K221131, Tasso+, by Tasso, Inc. https://foiadocs.com/products/fda-510k-k220540-progrip-self-gripping-polypropylene-mesh 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K220540, ProGrip Self-Gripping Polypropylene Mesh, by Covidien https://foiadocs.com/products/fda-510k-k160360-barrx-flex-rfa-energy-generator 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160360, Barrx FLEX RFA Energy Generator, by Covidien, LLC https://foiadocs.com/products/fda-510k-k213794-eko-murmur-analysis-software-emas 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K213794, Eko Murmur Analysis Software (EMAS), by Eko Devices, Inc. https://foiadocs.com/products/fda-510k-k212522-lilliput-apd-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K212522, Lilliput APD System, by Fresenius Medical Care Renal Therapies Group, LLC https://foiadocs.com/products/fda-510k-k192872-ulrichinject-ct-motion 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192872, ulrichINJECT CT Motion, by Ulrich GmbH & Co. KG https://foiadocs.com/products/fda-510k-k222093-v-pro-max-2-low-temperature-sterilization-system-v-pro-max-low-temperature-sterilization-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K222093, V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, by Steris https://foiadocs.com/products/fda-510k-k160327-aladdin-hw3-0 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160327, ALADDIN HW3.0, by Visia Imaging S.R.L. https://foiadocs.com/products/fda-510k-k052099-nasopore-nasal-dressing-model-ndox-yyy-zz 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K052099, NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ, by Polyganics B.V., https://foiadocs.com/products/fda-510k-k223269-spencer-probe-depth-electrodes 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K223269, Spencer Probe Depth Electrodes, by Ad-Tech Medical Instrument Corporation https://foiadocs.com/products/fda-510k-k203183-coolseal-trinity-30-cm-shaft-37-cm-shaft-and-44-cm-shaft 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203183, CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft), by Bolder Surgical, LLC https://foiadocs.com/products/fda-510k-k193007-lina-operascope-with-hdmi-cable-and-on-board-lcd-6-units-lina-operascope-recording-module 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K193007, LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module, by Lina Medical Aps https://foiadocs.com/products/fda-510k-k111738-chocolate-pta-balloon-catheter-over-the-wire-guide-wire-0-014-and-0-018 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K111738, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018), by Trireme Medical, Inc. https://foiadocs.com/products/fda-510k-k220567-easi-vue-embolic-microspheres-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K220567, Easi-Vue embolic microspheres System, by Abk Biomedical, Inc. https://foiadocs.com/products/fda-510k-k230358-savi-dual-tm-migraine-therapy 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K230358, SAVI Dual (TM) Migraine Therapy, by Eneura, Inc. https://foiadocs.com/products/fda-510k-k201238-encore-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K201238, Encore System, by Siesta Medical, Inc. https://foiadocs.com/products/fda-510k-k182073-bcss-picni-2000-sensor 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182073, BcSs-PICNI-2000 Sensor, by Braincare Desenvolvimento E Inovacao Tecnologica S.A. https://foiadocs.com/products/fda-510k-k201989-b4c-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K201989, B4C System, by Braincare Desenvolvimento E Inovacao Tecnologica S.A. https://foiadocs.com/products/fda-510k-k193622-trioclear-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K193622, TRIOCLEAR System, by Perfection Aligner System Hong Kong Limited https://foiadocs.com/products/fda-510k-k211010-illusion-aligners 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K211010, Illusion Aligners, by Laxmi Dental Exports Pvt, Ltd. https://foiadocs.com/products/fda-510k-k201104-asoaligner 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K201104, AsoAligner, by Aso International Manila, Inc. https://foiadocs.com/products/fda-510k-k013527-modification-to-synthes-usa-reamer-irrigator-aspirator-ria-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K013527, MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM, by Synthes (Usa) https://foiadocs.com/products/fda-510k-k042899-synthes-usa-ria-system-expanded-indications 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042899, SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS, by Synthes (Usa) https://foiadocs.com/products/fda-510k-k093479-disposable-suction-and-irrigation-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K093479, DISPOSABLE SUCTION AND IRRIGATION SYSTEM, by Modern Medical Equipment Mfg., Ltd. https://foiadocs.com/products/fda-510k-k030674-modification-to-axxess-spinal-cord-stimulation-lead 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K030674, MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD, by Advanced Neuromodulation Systems https://foiadocs.com/products/fda-510k-k192088-golnit-non-aborbable-ptfe-surgical-suture 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192088, GOLNIT Non-aborbable PTFE Surgical Suture, by Antarma, LLC Dba Golnit Sutures https://foiadocs.com/products/fda-510k-k041874-abl800-flex 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K041874, ABL800 FLEX, by Radiometer Medical Aps https://foiadocs.com/products/fda-510k-k173443-aeon-endoscopic-stapler 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173443, AEON Endoscopic Stapler, by Lexington Medical, Inc. https://foiadocs.com/products/fda-510k-k902305-trojan-naturalamb-natural-membrane-condom-w-sperm 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K902305, TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM., by Armkel, LLC https://foiadocs.com/products/fda-510k-k213198-ax-surgi-surgical-hemostat 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K213198, Ax-Surgi Surgical Hemostat, by Advamedica, Inc. https://foiadocs.com/products/fda-510k-k200167-quikclot-control 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200167, QuikClot Control+, by Z-Medica, LLC https://foiadocs.com/products/fda-510k-k781156-dialysis-sys-pds-400-ro-400 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K781156, DIALYSIS SYS., PDS 400 & RO 400, by Physio-Control Corp. https://foiadocs.com/products/fda-510k-k780082-peritoneal-dialysis-admin-set 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K780082, PERITONEAL DIALYSIS ADMIN. SET, by Physio-Control Corp. https://foiadocs.com/products/fda-510k-k202166-senhance-surgical-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K202166, Senhance Surgical System, by Transenterix, Inc. https://foiadocs.com/products/fda-510k-k163714-ossix-bone 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K163714, OSSIX BONE, by Datum Dental, Ltd. https://foiadocs.com/products/fda-510k-k213959-magnetos-flex-matrix 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K213959, MagnetOs Flex Matrix, by Kuros Biosciences B.V https://foiadocs.com/products/fda-510k-k231583-route-92-medical-full-length-054-access-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K231583, Route 92 Medical Full Length 054 Access System, by Route 92 Medical, Inc. https://foiadocs.com/products/fda-510k-k214048-millipede-088-access-catheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K214048, Millipede 088 Access Catheter, by Perfuze, Ltd. https://foiadocs.com/products/fda-510k-k220131-kyphon-vue-bone-cement 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K220131, KYPHON VuE Bone Cement, by Tecres S.P.A. https://foiadocs.com/products/fda-510k-k202752-axs-vecta-46-intermediate-catheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K202752, AXS Vecta 46 Intermediate Catheter, by Stryker Neurovascular https://foiadocs.com/products/fda-510k-k070714-medisize-gold-heater-and-booster 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K070714, MEDISIZE GOLD HEATER AND BOOSTER, by Medisize BV https://foiadocs.com/products/fda-510k-k110246-medisize-red-and-medisize-blue 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110246, MEDISIZE RED AND MEDISIZE BLUE, by Qserve America, Inc. https://foiadocs.com/products/fda-510k-k203722-raypilot-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203722, RayPilot System, by Micropos Medical AB https://foiadocs.com/products/fda-510k-k201778-i-stat-tbi-plasma-cartridge-with-the-i-stat-alinity-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K201778, i-STAT TBI Plasma cartridge with the i-STAT Alinity System, by Abbott Laboratories https://foiadocs.com/products/fda-510k-k143513-zio-sr-ecg-monitoring-service 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143513, ZIO SR ECG Monitoring Service, by iRhythm Technologies, Inc. https://foiadocs.com/products/fda-510k-k061711-oasis-wound-matrix 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061711, OASIS WOUND MATRIX, by Cook Biotech, Inc. https://foiadocs.com/products/fda-510k-k113808-the-sherlock-3cg-tip-confirmation-system-tcs 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K113808, THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS), by C.R. Bard, Inc. https://foiadocs.com/products/fda-510k-k170934-c3-wave-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K170934, C3 Wave System, by Medical Components, Inc (Dba Medcomp_ https://foiadocs.com/products/fda-510k-k143238-c3-wave 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143238, C3 Wave, by Medcomp ( Medical Components) https://foiadocs.com/products/fda-510k-k142889-celerity-picc-tip-confirmation-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142889, Celerity PICC Tip Confirmation System, by AngioDynamics, Inc. https://foiadocs.com/products/fda-510k-k140799-celerity-sysyem 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140799, CELERITY SYSYEM, by Medcomp (Medical Components, Inc.) https://foiadocs.com/products/fda-510k-k160925-vps-rhythm-device-with-tiptracker-technology 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160925, VPS Rhythm Device with TipTracker Technology, by Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) https://foiadocs.com/products/fda-510k-k152261-picc-tip-positioning-aid 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152261, PICC Tip Positioning Aid, by Nostix, LLC https://foiadocs.com/products/fda-510k-k103260-vascular-positioning-system-vps-system-console 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K103260, VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE, by Vasonova, Inc. https://foiadocs.com/products/fda-510k-k092746-micronjet-600 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092746, MICRONJET 600, by Nanopass Technologies , Ltd. https://foiadocs.com/products/fda-510k-k211855-ion-facet-screw-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K211855, Ion Facet Screw System, by SurGenTec, LLC https://foiadocs.com/products/fda-510k-k191352-binx-health-io-ct-ng-assay 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191352, binx health io CT/NG Assay, by Binx Health, Inc. https://foiadocs.com/products/fda-510k-k192051-thinq 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192051, THINQ, by Corticometrics, LLC https://foiadocs.com/products/fda-510k-k170981-neuroquant 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K170981, NeuroQuant, by Cortechs Labs, Inc. https://foiadocs.com/products/fda-510k-k221241-draid-for-radiology-v1 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K221241, DrAid for Radiology v1, by Vinbrain Joint Stock Company https://foiadocs.com/products/fda-510k-k220635-heater-cooler-system-3t 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K220635, Heater-Cooler System 3T, by Livanova Deutschland, GmbH https://foiadocs.com/products/fda-510k-k203835-mis-solution 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203835, MIS Solution, by Next Science, LLC https://foiadocs.com/products/fda-510k-k182687-motion-tracking-and-compensation-feature-for-the-radixact-treatment-delivery-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182687, Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System, by Accuray Incorporated https://foiadocs.com/products/fda-510k-k013037-excel-a-v-fisutal-needle-set 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K013037, EXCEL A.V FISUTAL NEEDLE SET, by Exelint Intl. Co. https://foiadocs.com/products/fda-510k-k232809-cross-vascular-rf-generator-and-footswitch-optional-accessory 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K232809, Cross Vascular RF Generator and Footswitch (optional accessory), by Cross Vascular, Inc. https://foiadocs.com/products/fda-510k-k210635-route-92-medical-full-length-088-access-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K210635, Route 92 Medical Full Length 088 Access System, by Route 92 Medical, Inc. https://foiadocs.com/products/fda-510k-k223893-infrared-heat-model-e0221 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K223893, Infrared Heat (Model: E0221), by Light Tree Ventures Europe B.V. https://foiadocs.com/products/fda-510k-k122885-medisize-gold-heater-and-booster-t-piece 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122885, MEDISIZE GOLD HEATER AND BOOSTER T-PIECE, by Medisize BV https://foiadocs.com/products/fda-510k-k974837-igelr-56-hefilcon-c-soft-hydrophlic-contact-lens 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K974837, IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS, by Igel Vision Care Pte , Ltd. https://foiadocs.com/products/fda-510k-k984523-igel-56-uv-hefilcon-c-soft-hydrophilic-contact-lens 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K984523, IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS, by Igel Vision Care Pte , Ltd. https://foiadocs.com/products/fda-510k-k102130-tenzing-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K102130, TENZING SYSTEM, by Mazor Surgical Technologies , Ltd. https://foiadocs.com/products/fda-510k-k081672-c-insight 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K081672, C-INSIGHT, by Mazor Surgical Technologies , Ltd. https://foiadocs.com/products/fda-510k-k082890-vnus-closurefast-intravascular-catheter-models-cf7-7-60-2-cf7-7-100-2 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082890, VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-7-100-2, by Vnus Medical Technologies, Inc. https://foiadocs.com/products/fda-510k-k800023-lung-aerosol-unit 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K800023, LUNG AEROSOL UNIT, by Cadema Medical Products, Inc. https://foiadocs.com/products/fda-510k-k042959-depuy-c-stem-amt-hip-prosthesis 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042959, DEPUY C-STEM AMT HIP PROSTHESIS, by DePuy Orthopaedics, Inc. https://foiadocs.com/products/fda-510k-k842493-agee-external-fixator 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K842493, AGEE EXTERNAL FIXATOR, by The Hand Biomechanics Research Laboratory https://foiadocs.com/products/fda-510k-k932725-b-d-ultra-finer-lancet 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K932725, B-D ULTRA FINE(R) LANCET, by Bd Becton Dickinson Vacutainer Systems Preanalytic https://foiadocs.com/products/fda-510k-k121710-xpert-ct-ng 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121710, XPERT CT/NG, by Cepheid https://foiadocs.com/products/fda-510k-k151589-bd-max-ct-gc-tv-bd-max-instrument 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151589, BD MAX CT/GC/TV, BD MAX INSTRUMENT, by Becton, Dickinson and Company https://foiadocs.com/products/fda-510k-k202280-cleerly-labs-v2-0 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K202280, Cleerly Labs v2.0, by Cleerly, Inc. https://foiadocs.com/products/fda-510k-k171589-aeon-endoscopic-stapler 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171589, AEON Endoscopic Stapler, by Lexington Medical, Inc. https://foiadocs.com/products/fda-510k-k182819-decanting-device 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182819, Decanting Device, by Gcmedica Enterprise Ltd.(Wuxi) https://foiadocs.com/products/fda-510k-k203459-safecross-transseptal-puncture-and-introducer-tsp-i-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203459, SafeCross Transseptal Puncture and Introducer (TSP/I) System, by East End Medical I, LLC https://foiadocs.com/products/fda-510k-k223517-clear-aligner 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K223517, Clear Aligner, by Wuxi EA Medical Instruments Technologies Limited. https://foiadocs.com/products/fda-510k-k230214-huma-rpm-rpm 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K230214, Huma RPM (RPM), by Medopad, Inc. https://foiadocs.com/products/fda-510k-k223209-elekta-unity 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K223209, Elekta Unity, by Elekta Solutions AB https://foiadocs.com/products/fda-510k-k231168-tracstar-ldp-large-distal-platform-zoom-88-large-distal-platform-zoom-88-large-distal-platform-support 2026-08-09T23:19:55-05:00 daily https://foiadocs.com/products/fda-510k-k203764-tracstar-large-distal-platform-zoom-88-large-distal-platform-zoom-88-t-large-distal-platform 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203764, TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform, by Imperative Care, Inc. https://foiadocs.com/products/fda-510k-k160907-depuy-actis-duofix-hip-prosthesis 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160907, DePuy Actis DuoFix Hip Prosthesis, by Depuy(Ireland) https://foiadocs.com/products/fda-510k-k081536-medisize-blue-medisize-green-medisize-red 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K081536, MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED, by Medisize BV https://foiadocs.com/products/fda-510k-k971329-ctf-systems-inc-whole-cortex-meg-system-with-optional-eeg-subsystem 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K971329, CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM), by Ctf Systems, Inc. https://foiadocs.com/products/fda-510k-k961800-head-mounted-display 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K961800, HEAD MOUNTED DISPLAY, by Vista Medical Technologies, Inc. https://foiadocs.com/products/fda-510k-k230632-versihd-with-guideme-software 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K230632, VersiHD with GuideMe software, by Nxstage Medical, Inc. https://foiadocs.com/products/fda-510k-k192525-087-balloon-guide-catheter-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192525, 087 Balloon Guide Catheter System, by Q'Apel Medical, LLC https://foiadocs.com/products/fda-510k-k230857-tilink-p-si-joint-fusion-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K230857, TiLink-P SI Joint Fusion System, by SurGenTec, LLC https://foiadocs.com/products/fda-510k-k182902-precision1 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182902, Precision1, by Alcon Laboratories, Inc. https://foiadocs.com/products/fda-510k-k192004-eko-analysis-software 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192004, Eko Analysis Software, by Eko Devices, Inc. https://foiadocs.com/products/fda-510k-k203043-route-92-medical-070-access-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203043, Route 92 Medical 070 Access System, by Route 92 Medical, Inc. https://foiadocs.com/products/fda-510k-k230775-sofia-ex-intracranial-support-catheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K230775, SOFIA EX Intracranial Support Catheter, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k190338-046-zenith-flex 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190338, 046 Zenith Flex, by Inneuroco, Inc. https://foiadocs.com/products/fda-510k-k210996-zoom-71-55-45-35-reperfusion-catheters-zoom-aspiration-tubing 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K210996, ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing, by Imperative Care, Inc. https://foiadocs.com/products/fda-510k-k220606-ambu-ascope-5-broncho-hd-5-6-2-8-ambu-ascope-5-broncho-hd-5-0-2-2-ambu-abox-2 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K220606, Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2, by Ambu A/S https://foiadocs.com/products/fda-510k-k222658-accurate-24-non-invasive-blood-pressure-monitor 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K222658, Accurate 24 Non-invasive blood pressure monitor, by Accurate Meditech, Inc. https://foiadocs.com/products/fda-510k-k220942-3m-attest-steam-chemical-integrators-1243a-1243b-1243re-1243res 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K220942, 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES), by 3M Company https://foiadocs.com/products/fda-510k-k193254-3m-attest-steam-chemical-integrator 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K193254, 3M Attest Steam Chemical Integrator, by 3M Company https://foiadocs.com/products/fda-510k-k150471-calcanail-orthopedic-arthrodesis-nail 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K150471, CalcaNail Orthopedic Arthrodesis Nail, by Fournitures Hospitalieres Industrie https://foiadocs.com/products/fda-510k-k181179-brainscope-one 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K181179, BrainScope One, by Brainscope Company, Inc. https://foiadocs.com/products/fda-510k-k083460-dialog-with-adimea-option 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K083460, DIALOG WITH ADIMEA OPTION, by B. Braun Avitum AG https://foiadocs.com/products/fda-510k-k212696-aspira-pleural-drainage-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K212696, Aspira Pleural Drainage System, by Merit Medical Systems, Inc. https://foiadocs.com/products/fda-510k-k043063-oxyband-wound-dressing 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K043063, OXYBAND WOUND DRESSING, by Oxyband Technologies, Inc. https://foiadocs.com/products/fda-drug-approval-a086195-proctofoam-hc 2026-08-09T23:19:55-05:00 daily https://foiadocs.com/products/fda-drug-approval-a212025-apomorphine-hydrochloride 2026-08-09T23:19:55-05:00 daily https://foiadocs.com/products/fda-510k-k182651-hba1c-advanced 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182651, HbA1c Advanced, by Beckman Coulter Ireland, Inc. https://foiadocs.com/products/fda-510k-k193053-tina-quant-hemoglobin-a1cdx-gen-3 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K193053, Tina-quant Hemoglobin A1cDx Gen.3, by Roche Diagnostics Operations (Rdo) https://foiadocs.com/products/fda-510k-k180329-clottriever-thrombectomy-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K180329, ClotTriever Thrombectomy System, by Inari Medical, Inc. https://foiadocs.com/products/fda-510k-k182531-clottriever-thrombectomy-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182531, ClotTriever Thrombectomy System, by Inari Medical https://foiadocs.com/products/fda-510k-k143054-sherpa-pak-kidney-transport-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143054, Sherpa Pak Kidney Transport System, by Paragonix Technologies, Inc. https://foiadocs.com/products/fda-510k-k102365-microplex-coil-system-cosmos 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K102365, MICROPLEX COIL SYSTEM- COSMOS, by MicroVention, Inc. https://foiadocs.com/products/fda-510k-k133209-foresee-4c-imaging-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K133209, FORESEE (4C) IMAGING SYSTEM, by Diagnostic Photonics, Inc. https://foiadocs.com/products/fda-pma-number-p910071-adatomed-silicone-oil-op5000 2026-08-09T23:19:55-05:00 daily https://foiadocs.com/products/fda-510k-k203192-navicam-xpress-stomach-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203192, NaviCam Xpress Stomach System, by Anx Robotica Corp https://foiadocs.com/products/fda-510k-k010849-vertex-etchant 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K010849, VERTEX ETCHANT, by Apex Dental Materials, Inc. https://foiadocs.com/products/fda-510k-k203215-radius-t-wearable-thermometer 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203215, Radius T wearable thermometer, by Masimo Corporation https://foiadocs.com/products/fda-510k-k201782-nuface-trinity-plus-device 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K201782, NuFace Trinity Plus Device, by Carol Cole Company Dba Nuface https://foiadocs.com/products/fda-510k-k171594-accuro 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171594, Accuro, by Rivanna Medical, LLC https://foiadocs.com/products/fda-510k-k071934-marrowstim-concentration-kit-and-marrowstim-mini-concentration-kit 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K071934, MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT, by Biomet Manufacturing Corp https://foiadocs.com/products/fda-510k-k940025-manan-bone-marrow-harvest-needles 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K940025, MANAN BONE MARROW HARVEST NEEDLES, by Manan Medical Products, Inc. https://foiadocs.com/products/fda-510k-k201906-trinity-ele-plus-and-trinity-ele-plus-pro 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K201906, Trinity ELE Plus and Trinity ELE Plus Pro, by Carol Cole Company Dba Nuface https://foiadocs.com/products/fda-510k-k182732-jtl-250-01 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182732, JTL-250-01, by Jointechlabs, Inc. https://foiadocs.com/products/fda-510k-k914241-pioneer-pro-pump-dual-control 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K914241, PIONEER PRO-PUMP DUAL CONTROL, by Pioneer Medical, Inc. https://foiadocs.com/products/fda-510k-k203373-advanced-research-medical-trident-si-screw-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203373, Advanced Research Medical Trident SI Screw System, by Advanced Research Medical, LLC https://foiadocs.com/products/fda-510k-k103305-penumbra-embolization-coil-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K103305, PENUMBRA EMBOLIZATION COIL SYSTEM, by Penumbra, Inc. https://foiadocs.com/products/fda-510k-k143218-penumbra-smart-coil 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143218, Penumbra Smart Coil, by Penumbra, Inc. https://foiadocs.com/products/fda-510k-k192955-penumbra-lp-coil-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192955, Penumbra LP Coil System, by Penumbra, Inc. https://foiadocs.com/products/fda-510k-k173614-penumbra-coil-400-ruby-coil-system-pod-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173614, Penumbra Coil 400, Ruby Coil System, POD System, by Penumbra, Inc. https://foiadocs.com/products/fda-510k-k193006-magventure-tms-therapy-for-treatment-of-ocd-magventure-tms-therapy-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K193006, MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system, by Tonica Elektronik A/S https://foiadocs.com/products/fda-510k-k033688-micro-h2-breath-monitoring-device-with-hydra-software-utility 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K033688, MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY, by Micro Direct, Inc. https://foiadocs.com/products/fda-510k-k061916-neuro-ii-se-models-or-mb-dr-and-or-dr 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K061916, NEURO II-SE, MODELS OR-MB-DR AND OR-DR, by Imris, Inc. https://foiadocs.com/products/fda-510k-k201992-caption-guidance 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K201992, Caption Guidance, by Caption Health https://foiadocs.com/products/fda-510k-k200621-caption-interpretation-automated-ejection-fraction-software 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200621, Caption Interpretation Automated Ejection Fraction Software, by Caption Health https://foiadocs.com/products/fda-510k-k200755-caption-guidance 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200755, Caption Guidance, by Caption Health https://foiadocs.com/products/fda-510k-k193670-sc-haemodialysis-machine-sc-dialysate-cartridge-sc-blood-tube-set 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K193670, SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set, by Quanta Dialysis Technologies, Ltd. https://foiadocs.com/products/fda-510k-k874752-gamow-hyperbaric-bag 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K874752, GAMOW HYPERBARIC BAG, by Hyperbaric Aerobics, Ltd. https://foiadocs.com/products/fda-510k-k760736-barimex-barium-sulfate-compound 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K760736, BARIMEX, BARIUM SULFATE COMPOUND, by C.R. Bard, Inc. https://foiadocs.com/products/fda-510k-k131405-ifuse-implant-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K131405, IFUSE IMPLANT SYSTEM, by SI-BONE, Inc. https://foiadocs.com/products/fda-510k-k062222-unitip-high-resolution-catheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062222, UNITIP HIGH RESOLUTION CATHETER, by Unisensor AG https://foiadocs.com/products/fda-510k-k142971-amt-bridle-nasal-tube-retention-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142971, AMT Bridle - Nasal Tube Retention System, by Applied Medical Technology, Inc. https://foiadocs.com/products/fda-510k-k060944-nutrisafe-2 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K060944, NUTRISAFE 2, by Vygon Corp. https://foiadocs.com/products/fda-510k-k191784-gabriel-feeding-tube-with-balloon-and-enfit-connector 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191784, Gabriel Feeding Tube with Balloon, and EnFit Connector, by Syncro Medical Innovations, Inc. https://foiadocs.com/products/fda-510k-k952542-ackrad-esophageal-balloon-catheter-set 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K952542, ACKRAD ESOPHAGEAL BALLOON CATHETER SET, by Ackrad Laboratories https://foiadocs.com/products/fda-510k-k031169-motility-visualization-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K031169, MOTILITY VISUALIZATION SYSTEM, by Sierra Scientific Instruments, Inc. https://foiadocs.com/products/fda-510k-k091070-manoscan-motility-with-impedance-visualization-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K091070, MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM, by Sierra Scientific Instruments, Inc. https://foiadocs.com/products/fda-510k-k151086-manoscan-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151086, ManoScan System, by Given Imaging , Ltd. https://foiadocs.com/products/fda-510k-k190208-diversatek-healthcare-high-resolution-impedance-manometry-hrim-probe 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190208, Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe, by Diversatek Healthcare https://foiadocs.com/products/fda-510k-k193416-cellvizio-i-v-e-with-confocal-miniprobes 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K193416, Cellvizio I.V.E. with Confocal Miniprobes, by Mauna Kea Technologies https://foiadocs.com/products/fda-510k-k211738-rotarex-atherectomy-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K211738, Rotarex Atherectomy System, by C.R. Bard, Inc. https://foiadocs.com/products/fda-510k-k141801-hawkone-directional-atherectomy-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K141801, HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM, by Covidien, LLC https://foiadocs.com/products/fda-510k-k011827-ortelius-800 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K011827, ORTELIUS 800, by Orthoscan , Ltd. https://foiadocs.com/products/fda-510k-k160016-steth-io 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K160016, Steth IO, by Stratoscientific, Inc. https://foiadocs.com/products/fda-510k-k161315-vein-clamps-artery-clamps 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161315, Vein Clamps, Artery Clamps, by Aros Surgical Instruments Corporation https://foiadocs.com/products/fda-510k-k961100-micro-anastomosis-clamp 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K961100, MICRO ANASTOMOSIS CLAMP, by R.S.P. Medical Management, Inc. https://foiadocs.com/products/fda-510k-k132904-ziehm-vision-rfd 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132904, ZIEHM VISION RFD, by Ziehm Imaging GmbH https://foiadocs.com/products/fda-510k-k171565-oec-elite 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171565, OEC Elite, by Ge Oec Medical Systems, Inc. https://foiadocs.com/products/fda-510k-k172735-wr19-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K172735, WR19 System, by Zeto, Inc. https://foiadocs.com/products/fda-510k-k203040-tsolution-one-total-knee-application 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203040, TSolution One Total Knee Application, by THINK Surgical, Inc. https://foiadocs.com/products/fda-510k-k191605-neocis-guidance-system-ngs 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191605, Neocis Guidance System (NGS), by Neocis, Inc. https://foiadocs.com/products/fda-510k-k200348-neocis-guidance-system-ngs-with-fiducial-array-splint-fas 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200348, Neocis Guidance System (NGS) with Fiducial Array Splint (FAS), by Neocis, Inc. https://foiadocs.com/products/fda-510k-k200805-neocis-guidance-system-ngs-with-patient-splints 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200805, Neocis Guidance System (NGS) with Patient Splints, by Neocis, Inc. https://foiadocs.com/products/fda-510k-k202264-neocis-guidance-system-ngs-with-yomi-plan-v2-0 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K202264, Neocis Guidance System (NGS) with Yomi Plan v2.0, by Neocis, Inc. https://foiadocs.com/products/fda-510k-k203401-neocis-guidance-system-ngs-with-patient-splints-eps 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K203401, Neocis Guidance System (NGS) with Patient Splints (EPS), by Neocis, Inc. https://foiadocs.com/products/fda-510k-k210668-tsolution-one-total-knee-application 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K210668, TSolution One Total Knee Application, by THINK Surgical, Inc. https://foiadocs.com/products/fda-510k-k211129-neocis-guidance-system-ngs-with-intraoral-fiducial-array 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K211129, Neocis Guidance System (NGS) with Intraoral Fiducial Array, by Neocis, Inc. https://foiadocs.com/products/fda-510k-k161399-neocis-guidance-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161399, Neocis Guidance System, by Neocis, Inc. https://foiadocs.com/products/fda-510k-k982577-neufinish-resurfacing-cream 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K982577, NEUFINISH RESURFACING CREAM, by Neutrogena Corp. https://foiadocs.com/products/fda-510k-k130368-autolith-touch-uro-touch 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K130368, AUTOLITH TOUCH; URO TOUCH, by Northgate Technologies, Inc. https://foiadocs.com/products/fda-510k-k162191-navilas-laser-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K162191, NAVILAS Laser System, by Od-Os GmbH https://foiadocs.com/products/fda-510k-k170724-neuroblate-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K170724, NeuroBlate System, by Monteris Medical, https://foiadocs.com/products/fda-510k-k171255-monteris-medical-neuroblate-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171255, Monteris Medical NeuroBlate System, by Monteris Medical, Inc. https://foiadocs.com/products/fda-510k-k172881-neuroblate-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K172881, NeuroBlate System, by Monteris Medical, https://foiadocs.com/products/fda-510k-k042936-solution-administration-with-luer-access-injection-site 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K042936, SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE, by Baxter Healthcare Corp https://foiadocs.com/products/fda-510k-k110771-bd-single-use-hypodermic-syringe 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K110771, BD SINGLE USE, HYPODERMIC SYRINGE, by Becton, Dickinson and Company https://foiadocs.com/products/fda-510k-k192880-inferread-lung-ct-ai 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192880, InferRead Lung CT.AI, by Beijing Infervision Technology Co., Ltd. https://foiadocs.com/products/fda-510k-k111520-ipc-powerease-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K111520, IPC POWEREASE SYSTEM, by Medtronic Xomed, Inc. https://foiadocs.com/products/fda-510k-k200761-tenax-laser-resistant-endotracheal-tube 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200761, Tenax Laser Resistant Endotracheal Tube, by Bryan Medical, Inc. https://foiadocs.com/products/fda-510k-k052643-epiceram 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K052643, EPICERAM, by Ceragenix Corporation https://foiadocs.com/products/fda-510k-k190719-artemis-eye-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190719, Artemis Eye System, by Penumbra, Inc. https://foiadocs.com/products/fda-510k-k171332-artemis-neuro-evacuation-device 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171332, Artemis Neuro Evacuation Device, by Penumbra, Inc. https://foiadocs.com/products/fda-510k-k211678-lunit-insight-mmg 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K211678, Lunit INSIGHT MMG, by Lunit, Inc. https://foiadocs.com/products/fda-510k-k181974-myosure-xl-tissue-removal-device-for-fluent 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K181974, MyoSure XL Tissue Removal Device for Fluent, by Hologic, Inc. https://foiadocs.com/products/fda-510k-k152723-myosure-hysteroscopic-tissue-removal-system-and-myosure-tissue-removal-devices 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152723, Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices, by Hologic, Inc. https://foiadocs.com/products/fda-510k-k171651-excelsius-gps 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171651, EXCELSIUS GPS, by Globus Medical, Inc. https://foiadocs.com/products/fda-510k-k191412-variax-2-system-variax-2-mini-fragment-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191412, VariAx 2 System, VariAx 2 Mini Fragment System, by Stryker GmbH https://foiadocs.com/products/fda-510k-k072883-ice-sense 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K072883, ICE-SENSE, by Arbel Medical , Ltd. https://foiadocs.com/products/fda-510k-k111943-agills-pf-delivery-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K111943, AGILLS PF DELIVERY SYSTEM, by St. Jude Medical, Cardiac Rhythm Management Divisi https://foiadocs.com/products/fda-510k-k200667-eyeart 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200667, EyeArt, by Eyenuk, Inc. https://foiadocs.com/products/fda-510k-k213622-cionic-neural-sleeve-ns-100 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K213622, Cionic Neural Sleeve NS-100, by Cionic https://foiadocs.com/products/fda-510k-k181363-ecovue-sterile-and-non-sterile-ultrasound-gels 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K181363, EcoVue Sterile and Non-Sterile Ultrasound Gels, by H R Pharmaceuticals, Inc. https://foiadocs.com/products/fda-510k-k163026-ultra-phonic-scanning-gel 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K163026, Ultra/Phonic Scanning Gel, by Pharmaceutical Innovations, Inc. https://foiadocs.com/products/fda-510k-k163050-advance-medical-designs-inc-sterile-ultrasound-gel 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K163050, Advance Medical Designs, Inc. Sterile Ultrasound Gel, by Advance Medical Designs, Inc. https://foiadocs.com/products/fda-510k-k182766-cufitec-surgical-mask 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K182766, Cufitec Surgical Mask, by Nbc Meshtec, Inc. https://foiadocs.com/products/fda-510k-k173730-kinsa-quickcare-thermometer 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K173730, Kinsa QuickCare Thermometer, by Kinsa, Inc. https://foiadocs.com/products/fda-510k-k212153-biobeat-platform-bb-613wp-patch 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K212153, Biobeat Platform, BB-613WP Patch, by Biobeat Technologies , Ltd. https://foiadocs.com/products/fda-510k-k191031-nightowl 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191031, NightOwl, by Ectosense NV https://foiadocs.com/products/fda-510k-k112822-sleepstrip-ii 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K112822, SLEEPSTRIP II, by S.L.P. , Ltd. https://foiadocs.com/products/fda-510k-k001852-peripheral-arterial-tonometer-pat-1000rd-device 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K001852, PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE, by Itamar Medical (C.M.) 1997 , Ltd. https://foiadocs.com/products/fda-510k-k181131-accu-chek-guide-me-blood-glucose-monitoring-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K181131, Accu-Chek Guide Me Blood Glucose Monitoring System, by Roche Diabetes Care https://foiadocs.com/products/fda-510k-k193659-itero-element-5d 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K193659, iTero Element 5D, by Align Technology, Inc. https://foiadocs.com/products/fda-510k-k172007-camx-triton-hd-proxi-head 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K172007, CamX Triton HD Proxi Head, by Duerr Dental AG https://foiadocs.com/products/fda-510k-k080355-leksell-stereotactic-system-with-reusable-fixation-screws 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080355, LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS, by Elekta Instrument AB https://foiadocs.com/products/fda-510k-k935189-e-z-derm-biosynthetic-wound-dressing 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K935189, E-Z DERM BIOSYNTHETIC WOUND DRESSING, by Brennen Medical, Inc. https://foiadocs.com/products/fda-510k-k951721-applied-medical-1-5mm-reusable-angioscope 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K951721, APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE, by Applied Medical Resources https://foiadocs.com/products/fda-510k-k190285-l300-go-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190285, L300 Go System, by Bioness, Inc. https://foiadocs.com/products/fda-510k-k090750-rt300-sl-model-fa100052-rt300-slsa-model-fa104581 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K090750, RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581, by Restorative Therapies, Inc. https://foiadocs.com/products/fda-510k-k183598-keyprint-keysplint-soft 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K183598, KeyPrint KeySplint Soft, by Keystone Industries https://foiadocs.com/products/fda-510k-k923996-disposable-vascular-angioscope 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K923996, DISPOSABLE VASCULAR ANGIOSCOPE, by Endovascular, Inc. https://foiadocs.com/products/fda-510k-k931464-baxter-coronary-angioscope-inflation-device 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K931464, BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE, by Baxter Healthcare Corp https://foiadocs.com/products/fda-510k-k952638-4-5f-imagecath-coronary-angioscope-model-cov45-subsequently-referred-to-as-the-modified-angioscope 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K952638, 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[, by Baxter Edwards https://foiadocs.com/products/fda-510k-k140054-rescan 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140054, RESCAN, by Resmed, Ltd. https://foiadocs.com/products/fda-510k-k151901-airview 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K151901, AirView, by Resmed, Ltd. https://foiadocs.com/products/fda-510k-k220195-ifuse-bedrock-granite%E2%84%A2-implant-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K220195, iFuse Bedrock Granite™ Implant System, by SI-BONE, Inc. https://foiadocs.com/products/fda-510k-k192731-zida-wearable-neuromodulation-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192731, ZIDA Wearable Neuromodulation System, by Exodus Innovations https://foiadocs.com/products/fda-510k-k220641-barrigel-injectable-gel 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K220641, Barrigel Injectable Gel, by Palette Life Sciences https://foiadocs.com/products/fda-510k-k183635-photofix-decellularized-bovine-pericardium 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K183635, PhotoFix Decellularized Bovine Pericardium, by Cryolife, Inc. https://foiadocs.com/products/fda-510k-k192764-neuroone-cortical-electrode 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192764, NeuroOne Cortical Electrode, by Neuroone, Inc. https://foiadocs.com/products/fda-510k-k072002-filter-carestar-30-filter-safestar-55-filter-hme-twinstar-55 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K072002, FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55, by Draeger Medical AG & Co. KG https://foiadocs.com/products/fda-510k-k190593-zio-xt-ecg-monitoring-system-zio-at-ecg-monitoring-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190593, Zio XT ECG Monitoring System, Zio AT ECG Monitoring System, by iRhythm Technologies, Inc. https://foiadocs.com/products/fda-510k-k220411-reprocessed-ligasure-curved-small-jaw-open-sealer-divider-lf1212a 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K220411, Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A), by Stryker Sustainability Solutions https://foiadocs.com/products/fda-510k-k181661-qxdx-bcr-abl-is-kit-for-use-on-the-qxdx-autodg-ddpcr-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K181661, QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System, by Bio-Rad Laboratories, Inc. https://foiadocs.com/products/fda-510k-k001401-amt-therapeutic-table-model-748amt 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K001401, AMT THERAPEUTIC TABLE, MODEL 748AMT, by Amt Mfg., Inc. https://foiadocs.com/products/fda-510k-k071079-spectra-optia-apheresis-system-spectra-optia-exchange-set-model-61000-10200 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K071079, SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200, by Gambro Bct, Inc. https://foiadocs.com/products/fda-510k-k161487-vpap-adapt-sv-vpap-tx-s9-vpap-tx 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161487, VPAP Adapt SV, VPAP Tx, S9 VPAP Tx, by Resmed, Ltd. https://foiadocs.com/products/fda-510k-k212871-aliyatm-system-aliyatm-generator-aliyatm-needle-aliyatm-electrode 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K212871, Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode, by Galvanize Therapeutics, Inc. https://foiadocs.com/products/fda-510k-k212616-koios-ds 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K212616, Koios DS, by Koios Medical, Inc. https://foiadocs.com/products/fda-510k-k191272-wearable-device-wearable-package 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191272, Wearable Device, Wearable Package, by Current Health , Ltd. https://foiadocs.com/products/fda-510k-k972699-aesop-3000-system-and-accessories 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K972699, AESOP 3000 SYSTEM AND ACCESSORIES, by Computer Motion, Inc. https://foiadocs.com/products/fda-510k-k213037-idx-dr-v2-3 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K213037, IDx-DR v2.3, by Digital Diagnostics, Inc. https://foiadocs.com/products/fda-510k-k143577-xw-100-automated-hematology-analyzer-xw-qc-check 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K143577, XW-100 Automated Hematology Analyzer, XW QC CHECK, by Sysmex America, Inc. https://foiadocs.com/products/fda-510k-k080950-stiwell-med4 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K080950, STIWELL MED4, by Otto Bock, Austria GmbH https://foiadocs.com/products/fda-510k-k201290-medline-denovo-4pro-electrical-stimulation-device 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K201290, Medline DeNovo 4Pro Electrical Stimulation Device, by Medline Industries, Inc. https://foiadocs.com/products/fda-510k-k103081-covaortho-nerve-resorbable-collagen-membrane 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K103081, COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE, by Biom'Up Sas https://foiadocs.com/products/fda-510k-k142461-vascu-guard-peripheral-vascular-patch 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K142461, VASCU-GUARD Peripheral Vascular Patch, by Synovis Life Technologies, Inc. https://foiadocs.com/products/fda-510k-k162741-axoguard-nerve-connector 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K162741, AxoGuard Nerve Connector, by Cook Biotech Incorporated https://foiadocs.com/products/fda-510k-k152967-nerbridge 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152967, NERBRIDGE, by Toyobo Co., Ltd. https://foiadocs.com/products/fda-510k-k171899-revitalair-430f 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171899, Revitalair 430F, by Oxavita Srl https://foiadocs.com/products/fda-510k-k212947-trinity-plus-wrinkle-reducer 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K212947, Trinity Plus Wrinkle Reducer, by Carol Cole Company Dba Nuface https://foiadocs.com/products/fda-510k-k181451-uretero-reno-videoscope-olympus-urf-v3-v3r-uretero-reno-fiberscope-olympus-urf-p7-p7r 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K181451, URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R, by Olympus Medical Systems Corp. https://foiadocs.com/products/fda-510k-k181240-rhino-laryngo-fiberscope-olympus-enf-gp2 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K181240, Rhino-Laryngo Fiberscope Olympus ENF-GP2, by Olympus Medical Systems Corp. https://foiadocs.com/products/fda-510k-k062049-evis-exera-ii-180-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K062049, EVIS EXERA II 180 SYSTEM, by Olympus Medical Systems Corporation https://foiadocs.com/products/fda-510k-k140300-collagen-tendon-sheet-ddi-cts-ddi 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K140300, COLLAGEN TENDON SHEET-DDI (CTS-DDI), by Rotation Medical, Inc. https://foiadocs.com/products/fda-510k-k162770-relign-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K162770, Relign System, by Relign Corporation https://foiadocs.com/products/fda-510k-k121700-ulthera-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K121700, ULTHERA SYSTEM, by Ulthera, Inc. https://foiadocs.com/products/fda-510k-k172284-napa-lp-15-airway-pressure-monitor 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K172284, NAPA LP-15 Airway Pressure Monitor, by Drw Medical, LLC https://foiadocs.com/products/fda-510k-k132431-thermage-cpt-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K132431, THERMAGE CPT SYSTEM, by Solta Medical, Inc. https://foiadocs.com/products/fda-510k-k082930-cardiva-catalyst-iii-system-with-protamine-sulfate 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K082930, CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE, by Cardiva Medical, Inc. https://foiadocs.com/products/fda-510k-k212797-iprime-viscodelivery-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K212797, iPrime Viscodelivery System, by Glaukos https://foiadocs.com/products/fda-510k-k200599-digital-thermometer 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200599, Digital Thermometer, by Joytech Healthcare Co. , Ltd. https://foiadocs.com/products/fda-510k-k211785-cassatt%E2%84%A2-sij-fixation-system 2026-08-09T23:19:55-05:00 daily https://foiadocs.com/products/fda-510k-k092156-cad-12-colonoscopy-assist-device 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K092156, CAD 12, COLONOSCOPY ASSIST DEVICE, by Softscope Medical Technologies, Inc. https://foiadocs.com/products/fda-510k-k221183-aeye-ds 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K221183, AEYE-DS, by Aeye Health, Inc. https://foiadocs.com/products/fda-510k-k221007-cobas-hcv 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K221007, cobas HCV, by Roche Molecular Systems, Inc. https://foiadocs.com/products/fda-510k-k181557-infinity-total-ankle-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K181557, INFINITY Total Ankle System, by Wrightmedicaltechnologyinc https://foiadocs.com/products/fda-510k-k122702-biofriend-biomask-n95-surgical-respirator 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K122702, BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR, by Filligent Limited https://foiadocs.com/products/fda-510k-k944699-att-300 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K944699, ATT-300, by Health Care Mfg., Inc. https://foiadocs.com/products/fda-510k-k210133-current-health-monitoring-system-gen-2-g2 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K210133, Current Health Monitoring System Gen 2 (G2), by Current Health https://foiadocs.com/products/fda-510k-k193293-xv-lung-ventilation-analysis-software 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K193293, XV Lung Ventilation Analysis Software, by 4Dx Limited https://foiadocs.com/products/fda-510k-k190292-passio-pump-drainage-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K190292, Passio Pump Drainage System, by Bearpac Medical https://foiadocs.com/products/fda-510k-k201404-passio-pump-drainage-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K201404, Passio Pump Drainage System, by Bearpac Medical https://foiadocs.com/products/fda-510k-k171392-ulrichinject-ct-motion 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171392, ulrichINJECT CT motion, by Ulrich GmbH & Co. KG https://foiadocs.com/products/fda-510k-k202546-lvivo-seamless 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K202546, LVivo Seamless, by Dia Imaging Analysis, Ltd. https://foiadocs.com/products/fda-510k-k200232-lvivo-software-application 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200232, LVivo Software Application, by Dia Imaging Analysis, Ltd. https://foiadocs.com/products/fda-510k-k161382-lvivo-software-application 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K161382, LVivo Software Application, by Diacardio, Ltd. https://foiadocs.com/products/fda-510k-k220997-wireless-tens-ems-bruno-aela 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K220997, Wireless TENS/EMS, Bruno, Aela, by Zmi Elecronics , Ltd. https://foiadocs.com/products/fda-510k-k200404-orise-proknife 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200404, ORISE ProKnife, by Boston Scientific Corporation https://foiadocs.com/products/fda-510k-k193601-single-use-electrosurgical-knife 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K193601, Single Use Electrosurgical Knife, by Micro-Tech (Nanjing) Co., Ltd. https://foiadocs.com/products/fda-510k-k912645-atriums-pdr-thoracic-catheter 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K912645, ATRIUMS PDR THORACIC CATHETER, by Atrium Medical Corp. https://foiadocs.com/products/fda-510k-k213854-savvywire 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K213854, SavvyWire, by Opsens, Inc. https://foiadocs.com/products/fda-510k-k152494-zimmer-nexgen-complete-knee-solution-tibial-and-femoral-augments 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K152494, Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments, by Zimmer, Inc. https://foiadocs.com/products/fda-510k-k172765-smart-moves-complete 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K172765, Smart Moves Complete, by Great Lakes Orthodontics, Ltd. https://foiadocs.com/products/fda-510k-k013056-gelclair-concentrated-oral-gel 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K013056, GELCLAIR CONCENTRATED ORAL GEL, by Sinclair Pharmaceuticals, Ltd. https://foiadocs.com/products/fda-510k-k021481-bresagen-catheter-model-cs-3000 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K021481, BRESAGEN CATHETER, MODEL CS-3000, by Bresagen, Inc. https://foiadocs.com/products/fda-510k-k212156-abccolla-bone-matrix 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K212156, ABCcolla Bone Matrix, by Acro Biomedical Co., Ltd. https://foiadocs.com/products/fda-510k-k103561-menicon-z-tisilfocon-a-rigid-gas-permeable-contact-lens 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K103561, MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS, by Menicon Co, Ltd. https://foiadocs.com/products/fda-510k-k211878-liquiband-xl 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K211878, LiquiBand XL, by Advanced Medical Solutions Limited https://foiadocs.com/products/fda-510k-k972382-ub-analyzer-ua-2-reagent-kit-and-bilirubin-control 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K972382, UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL, by Arrows Co., Ltd. https://foiadocs.com/products/fda-510k-k953763-gladiator-antishock-pants 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K953763, GLADIATOR ANTISHOCK PANTS, by Jobst Institute, Inc. https://foiadocs.com/products/fda-510k-k220205-3d-anatomic-models 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K220205, 3D Anatomic Models, by Ricoh USA, Inc. https://foiadocs.com/products/fda-510k-k123701-hearlab-aca 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K123701, HEARLAB ACA, by Frye Electronics, Inc. https://foiadocs.com/products/fda-510k-k192415-study-watch-with-irregular-pulse-monitor 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K192415, Study Watch with Irregular Pulse Monitor, by Verily Life Sciences, LLC https://foiadocs.com/products/fda-510k-k942543-aneroid-sphygmomanometers-mercurial-sphygmomanometersrs 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K942543, ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS, by Sankei Co., Ltd. https://foiadocs.com/products/fda-510k-k213562-dtx-studio-clinic-3-0 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K213562, DTX Studio Clinic 3.0, by Nobel Biocare AB https://foiadocs.com/products/fda-510k-k990519-phoenix-epidural-spinal-needles 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K990519, PHOENIX EPIDURAL & SPINAL NEEDLES, by Myco Medical Supplies, Inc. https://foiadocs.com/products/fda-510k-k171414-qeeg-pro 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K171414, qEEG-Pro, by Brainmaster Technologies, Inc. https://foiadocs.com/products/adverse-events-elevidys-delandistrogene-moxeparvovec 2026-08-09T23:19:55-05:00 daily https://foiadocs.com/products/adverse-events-syfovre 2026-08-09T23:19:55-05:00 daily https://foiadocs.com/products/fda-510k-k191236-3ma-attesta-steam-chemical-integrators 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K191236, 3M™ Attest™ Steam Chemical Integrators, by 3M Company https://foiadocs.com/products/fda-510k-k153057-fitritea-total-hip-arthroplasty-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K153057, FitRite™ Total Hip Arthroplasty System, by Excera Orthopedics, Inc. https://foiadocs.com/products/fda-510k-k212758-autoplaque 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K212758, Autoplaque, by Cedars-Sinai Medical Center: Aim https://foiadocs.com/products/fda-510k-k200037-piccolo-medical-smartpicc-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K200037, Piccolo Medical SmartPICC System, by Piccolo Medical, Inc. https://foiadocs.com/products/fda-510k-k201199-jada-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K201199, Jada System, by Alydia Health https://foiadocs.com/products/fda-510k-k180567-c3-wave-system 2026-08-09T23:19:55-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400 FDA 510(k) K180567, C3 Wave System, by Medical Components, Inc. 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