510(k) Clearances in 2019

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 1 of 59)
510(k) clearancesDetails
K192444 — mCare® Powder Free Nitrile Black Examination GloveMercator Medical (Thailand), Ltd. Dec 31, 2019
K192578 — InCore TMT SystemNextremity Solutions, Inc. Dec 31, 2019
K192912 — AutoMIStarApollo Medical Imaging Technology Pty. , Ltd. Dec 31, 2019
K190990 — Digital ThermometerXiamen Ants Bro Technology Co., Ltd. Dec 31, 2019
K192343 — Patient MonitorShenzhen Creative Industry Co., Ltd. Dec 31, 2019
K193381 — RadCalc SoftwareLifeline Software, Inc. Dec 31, 2019
K192655 — Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC Dec 30, 2019
K192258 — Disposable Valve SetsZhejiang Chuangxiang Medical Technology Co., Ltd. Dec 30, 2019
K190241 — Sterile Latex Surgical Glove, Powder FreeCareglove Global Sdn. Bhd. Dec 30, 2019
K193149 — True 3D Viewer SoftwareEchopixel, Inc. Dec 27, 2019
K192700 — XcamHdx Will Corp. Dec 27, 2019
K193403 — UroNav SystemInvivo Corporation Dec 27, 2019
K191256 — Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG Dec 27, 2019
K192695 — InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD , Ltd. Dec 27, 2019
K191059 — Masimo Rad-97 and AccessoriesMasimo Corporation Dec 27, 2019
K192939 — Volumetric Specimen ImagerClarix Imaging Dec 27, 2019
K192196 — Medical Radiation Dosimetry System microSTARiiLandauer Dec 27, 2019
K191696 — Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue GraftCook Biotech Incorporated Dec 27, 2019
K190467 — iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. Dec 26, 2019
K190884 — TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery ToolDatascope Corp. Dec 26, 2019
K193050 — Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral StemZimmer GmbH Dec 26, 2019
K192768 — Temporary Fixation PinsEisertech, LLC Dec 26, 2019
K192135 — VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)MicroVention, Inc. Dec 24, 2019
K191551 — RIST Cath Radial Access Long SheathRist Neurovascular, Inc. Dec 23, 2019
K190860 — Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange colorEver Growth (Vietnam) Co. , Ltd. Dec 23, 2019
DEN180067 — Mucosal Integrity Conductivity (MI) Test SystemDiversatek Healthcare, Inc. Dec 23, 2019
K190736 — Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy DrugsEver Growth (Vietnam) Co. , Ltd. Dec 23, 2019
K192485 — BioCode Respiratory Pathogen Panel (RPP)Applied BioCode, Inc. Dec 23, 2019
K192104 — Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs)Medline Industries, Inc. Dec 23, 2019
K192023 — Arm Blood Pressure MonitorTruly Instrument Limited Dec 23, 2019
K192733 — RelieforMe TENS/EMS Device Model UPK-GE01Umeheal , Ltd. Dec 23, 2019
K190665 — Neodent Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A. Dec 23, 2019
K191960 — Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc. Dec 23, 2019
K192487 — EZ-TRAX Containment DeviceK1 Medical, LLC Dec 23, 2019
K182718 — Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. Dec 23, 2019
K193279 — Comet II Pressure GuidewireBoston Scientific Corporation Dec 23, 2019
K192645 — Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. Dec 23, 2019
K193254 — 3M Attest Steam Chemical Integrator3M Company Dec 23, 2019
K191846 — MAXReach Laser ProbeVortex Surgical, Inc. Dec 23, 2019
K192559 — Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG Dec 21, 2019
K192629 — SpinalyticsOptima Health Solutions International Corp. Dec 21, 2019
K191666 — Unscented W long plastic and cardboard applicator tamponsOntex Bvba Dec 20, 2019
K193230 — Ziehm Vision FDZiehm Imaging GmbH Dec 20, 2019
K191823 — Clear-AlignersCdb Corporation Dec 20, 2019
K192470 — DenMat Orthodontic AlignersDenmat Holdings, LLC Dec 20, 2019
K190730 — IODOSORBSmith & Nephew Medical, Ltd. Dec 20, 2019
K192833 — Indigo Aspiration SystemPenumbra, Inc. Dec 20, 2019
K190633 — NanoOrtho NanoKnee® SystemNanoortho, LLC Dec 20, 2019
K192471 — RHIN1 StylusAerin Medical, Inc. Dec 20, 2019
K191836 — Ceramill A-SplintAmann Girrbach AG Dec 20, 2019
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