510(k) Clearances in 2023 — Page 45

3,346 510(k) clearances total

Browse FDA 510(k) clearances granted in 2023. RegDataLab tracks 3,346 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2023 (page 45 of 67)
510(k) clearancesDetails
K230358 — SAVI Dual (TM) Migraine TherapyEneura, Inc. May 16, 2023
K222560 — BlueCheck™ Caries Detection & MonitoringIncisive Technologies Pty, Ltd. May 16, 2023
K222024 — Evita V800, Evita V600Draegerwerk AG & CO Kgaa May 16, 2023
K230262 — BruxZir™ Incisal Coloring LiquidPrismatik Dentalcraft, Inc. May 16, 2023
K222736 — Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. May 16, 2023
K222912 — c1TracZimmer Medizinsysteme GmbH May 16, 2023
K222812 — InsufflatorScivita Medical Technology Co., Ltd. May 16, 2023
K230219 — Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC May 16, 2023
K222254 — Gunther Tulip Vena Cava Filter Retrieval SetCook Incorporated May 16, 2023
K223893 — Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V. May 16, 2023
K231391 — Combi TouchMectron S.P.A. May 15, 2023
K223836 — Vathin® Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd. May 15, 2023
K222836 — Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG May 15, 2023
K231081 — Dexcom G7 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. May 15, 2023
K220526 — HD+12, HD+15Cardioline S.P.A May 15, 2023
K230121 — Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)Careglove Global Sdn. Bhd. May 15, 2023
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 May 15, 2023
K223147 — myLEDmaskMyblend May 14, 2023
K230217 — Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd. May 13, 2023
K223308 — HEATING TENS/EMS, FT-810RHivox Biotek, Inc. May 13, 2023
K221969 — IU Implant System AbutmentWarantec Co., Ltd. May 12, 2023
K230684 — RadiForce MX217Eizo Corporation May 12, 2023
K222460 — Intraoperative Ultrasound Probe CoverExact Medical Manufacturing May 12, 2023
K230975 — Ahmed® Glaucoma Valve Model FP7New World Medical, Inc. May 12, 2023
K231190 — EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC May 12, 2023
K223101 — BD Secondary Infusion SetCare Fusion May 12, 2023
K231224 — da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc. May 12, 2023
K231051 — Ahmed® Glaucoma Valve Model FP8New World Medical, Inc. May 12, 2023
K222106 — Waypoint GPSWaypoint Orthopedics, Inc. May 12, 2023
K222489 — Harvest Printable ResinHarvest Dental Products, LLC May 12, 2023
K230394 — EUROSCREW NG; EUROSCREW TCP NGTeknimed May 12, 2023
K223706 — PMMA BLOCKHuliang(Shanghai) Bio-Tech Co., Ltd. May 12, 2023
K222854 — iTFlowCardio Flow Design, Inc. May 12, 2023
K230414 — ClariVy™ Cervical IBF SystemVy Spine, LLC May 12, 2023
K231063 — SOMAVAC® 100 Sustained Vacuum SystemSomavac Medical Solutions, Inc. May 12, 2023
K230550 — JAWS Nitinol Staple SystemParagon 28, Inc. May 11, 2023
K231052 — ExacTrac Dynamic 1.1.2Brainlab AG May 11, 2023
K222501 — Regeneten Bioinductive ImplantSmith And Nephew, Inc. May 11, 2023
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 May 11, 2023
K223623 — SubtleMR (2.3.x)Subtle Medical, Inc. May 11, 2023
K222549 — OpenTexPurgo Biologics, Inc. May 11, 2023
K223265 — CryoX Vitrification Freeze Kit / Thaw KitZhejiang Horizon Medical Technology Co., Ltd. May 11, 2023
K230280 — ANDORATE® Suction Valve and ANDORATE® Biopsy ValveGa Health Company Limited May 11, 2023
K231338 — 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment3M Espe Dental Products May 10, 2023
K223624 — Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental May 10, 2023
K222987 — Akunah REFLECTAkunah Pty, Ltd. May 10, 2023
K221127 — Sientra, inc. PortfinderSientra, Inc. May 10, 2023
K230491 — HandX™ Monopolar ScissorsHuman Xtensions , Ltd. May 10, 2023
K220437 — Neurophet AQUANeurophet., Inc. May 10, 2023
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. May 10, 2023
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