510(k) Clearances

174,759 clearances total

K223437 — Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)Hartalega NGC Sdn. Bhd. Wed May 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222728 — Radiation Planning Assistant (RPA)University of Texas, MD Anderson Cancer Center Wed May 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231102 — Symbia Pro.specta VA20A FamilySiemens Medical Solutions USA, Inc. Wed May 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K220964 — VERSAJET Hydrosurgery System (III)Smith & Nephew Medical Limited Tue May 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222560 — BlueCheck™ Caries Detection & MonitoringIncisive Technologies Pty, Ltd. Tue May 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230262 — BruxZir™ Incisal Coloring LiquidPrismatik Dentalcraft, Inc. Tue May 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222736 — Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. Tue May 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230358 — SAVI Dual (TM) Migraine TherapyEneura, Inc. Tue May 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222024 — Evita V800, Evita V600Draegerwerk AG & CO Kgaa Tue May 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222207 — Babylog VN800, Babylog VN600Draegerwerk AG & CO Kgaa Tue May 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222912 — c1TracZimmer Medizinsysteme GmbH Tue May 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222812 — InsufflatorScivita Medical Technology Co., Ltd. Tue May 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230219 — Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC Tue May 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222254 — Gunther Tulip Vena Cava Filter Retrieval SetCook Incorporated Tue May 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223893 — Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V. Tue May 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223836 — Vathin® Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd. Mon May 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222836 — Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG Mon May 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231081 — Dexcom G7 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. Mon May 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K220526 — HD+12, HD+15Cardioline S.P.A Mon May 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230121 — Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)Careglove Global Sdn. Bhd. Mon May 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K202993 — Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H)Mmj Labs, LLC Mon May 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231391 — Combi TouchMectron S.P.A. Mon May 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223147 — myLEDmaskMyblend Sun May 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230217 — Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd. Sat May 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223308 — HEATING TENS/EMS, FT-810RHivox Biotek, Inc. Sat May 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231051 — Ahmed® Glaucoma Valve Model FP8New World Medical, Inc. Fri May 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223706 — PMMA BLOCKHuliang(Shanghai) Bio-Tech Co., Ltd. Fri May 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223101 — BD Secondary Infusion SetCare Fusion Fri May 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231190 — EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC Fri May 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222460 — Intraoperative Ultrasound Probe CoverExact Medical Manufacturing Fri May 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230684 — RadiForce MX217Eizo Corporation Fri May 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222106 — Waypoint GPSWaypoint Orthopedics, Inc. Fri May 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222489 — Harvest Printable ResinHarvest Dental Products, LLC Fri May 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K221969 — IU Implant System AbutmentWarantec Co., Ltd. Fri May 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230394 — EUROSCREW NG; EUROSCREW TCP NGTeknimed Fri May 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222854 — iTFlowCardio Flow Design, Inc. Fri May 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230414 — ClariVy™ Cervical IBF SystemVy Spine, LLC Fri May 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230975 — Ahmed® Glaucoma Valve Model FP7New World Medical, Inc. Fri May 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231063 — SOMAVAC® 100 Sustained Vacuum SystemSomavac Medical Solutions, Inc. Fri May 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231224 — da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc. Fri May 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230550 — JAWS Nitinol Staple SystemParagon 28, Inc. Thu May 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222501 — Regeneten Bioinductive ImplantSmith and Nephew, Inc. Thu May 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231052 — ExacTrac Dynamic 1.1.2Brainlab AG Thu May 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223623 — SubtleMR (2.3.x)Subtle Medical, Inc. Thu May 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222549 — OpenTexPurgo Biologics, Inc. Thu May 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K220721 — FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000Fresenius Medical Care Renal Therapies Group, LLC Thu May 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223265 — CryoX Vitrification Freeze Kit / Thaw KitZhejiang Horizon Medical Technology Co., Ltd. Thu May 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230280 — ANDORATE® Suction Valve and ANDORATE® Biopsy ValveGa Health Company Limited Thu May 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230491 — HandX™ Monopolar ScissorsHuman Xtensions , Ltd. Wed May 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222870 — Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039Shenzhen Kentro Medical Electronics Co., Ltd. Wed May 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
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