510(k) Clearances in 2019 — Page 3

2,918 510(k) clearances total

Browse FDA 510(k) clearances granted in 2019. RegDataLab tracks 2,918 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2019 (page 3 of 59)
510(k) clearancesDetails
K192580 — STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc. Dec 18, 2019
K190824 — Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/PediatricBluepoint Medical GmbH & Co. KG Dec 18, 2019
K190012 — OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd. Dec 18, 2019
K192680 — Percusys® Plus Pedicle Screw SystemJoimax GmbH Dec 18, 2019
K192584 — BEACON Caresystem Model 00002144Mermaid Care A/S Dec 18, 2019
K182476 — Disposable Powered Articulating Endoscopic Linear Cutter Stapler & ReloadsFengh Medical Co., Ltd. Dec 18, 2019
K192189 — Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc. Dec 18, 2019
K192670 — Neodent Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A. Dec 18, 2019
K191898 — Sterile Latex Powder-Free Surgical GlovesModern Healthcare Corp. Dec 18, 2019
K191614 — BioSticker SystemBiointellisense, Inc. Dec 18, 2019
K191087 — IntraMarX Radiopaque MarkersAnx Robotica Corp Dec 18, 2019
K192572 — CNS EnvisionMoberg Research, Inc. Dec 17, 2019
K192267 — ILUMIEN System with AptiVue Software version D.3ABBOTT MEDICAL Dec 17, 2019
K192595 — ExSpiron 2XiRespiratory Motion Dec 17, 2019
K190725 — Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, WhiteRiverstone Resources Sdn Bhd Dec 17, 2019
K192615 — Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.) Dec 17, 2019
K191758 — Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc. Dec 17, 2019
K193219 — G Surgical Marksman SystemG Surgical, LLC Dec 17, 2019
K193179 — EV1000 Clinical PlatformEdwards Lifesciences, LLC Dec 17, 2019
K192450 — Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC Dec 17, 2019
K192249 — InMode System with Tone ApplicatorInMode , Ltd. Dec 17, 2019
K192763 — syngo.CT CaScoringSiemens Medical Solutions USA, Inc. Dec 17, 2019
K193039 — Single Use Balloon Dilator V (with knife)Olympus Medical Systems Corp. Dec 17, 2019
K193071 — Bashir Plus Endovascular CatheterThrombolex, Inc. Dec 17, 2019
K192539 — Deka LuxeaEl.En Electronic Engineering Spa Dec 16, 2019
K191306 — Llis, Vittra APSDentscare Ltda Dec 16, 2019
K192943 — CEDIA Heroin Metabolite (6-AM) assayMicrogenics Corporation Dec 16, 2019
K191751 — EM ProvisionalHiossen, Inc. Dec 16, 2019
K192762 — Physio Flex Annuloplasty RingEdwards Lifesciences, LLC Dec 16, 2019
K192744 — CORRIDOR Fixation SystemGlobus Medical, Inc. Dec 16, 2019
K191834 — Stand-Alone ALIF Titanium SystemLife Spine, Inc. Dec 16, 2019
K181548 — Pantheon Spinal Pontus Interbody Fusion DevicePantheon Spinal Dec 16, 2019
K190903 — Lawson Retrograde Nephrostomy Wire Puncture SetCook Incorporated Dec 16, 2019
K193174 — Keos Lumbar IBFDKeos Dec 16, 2019
K190394 — SunClear Aligner systemSun Dental Laboratories, LLC Dec 16, 2019
K190833 — AXS Vecta Aspiration CatheterStryker Neurovascular Dec 15, 2019
K192356 — Airlock Centrolock Osteosynthesis Implant SystemNovastep Dec 14, 2019
K190717 — Infrared Thermometer, model: PC808Shenzhen Pacom Medical Instruments Co., Ltd. Dec 13, 2019
K182731 — Corelink Navigation InstrumentsCorelink, LLC Dec 13, 2019
K190715 — EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll StandInterscope, Inc. Dec 13, 2019
K192569 — Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd. Dec 13, 2019
K190752 — SatisfaiteFemmepharma Consumer Healthcare, LLC Dec 13, 2019
K193162 — EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc. Dec 13, 2019
K191796 — Neo Cage SystemNeo Medical SA Dec 13, 2019
K192531 — QyScore SoftwareQynapse Dec 13, 2019
K191118 — Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc. Dec 13, 2019
K192627 — Laser Hair Growth CapShang FA Biotechnology Co. Dec 13, 2019
K193170 — Deep Learning Image ReconstructionGe Healthcare Japan Corporation Dec 13, 2019
K193317 — CoreLite X-Ray Specimen CabinetCirdan Imaging Limited Dec 13, 2019
K193173 — CareView 1800LeCareray Digital Medical System Co., Ltd. Dec 13, 2019
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