510(k) Clearances in 2021 — Page 50

3,023 510(k) clearances total

Browse FDA 510(k) clearances granted in 2021. RegDataLab tracks 3,023 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2021 (page 50 of 61)
510(k) clearancesDetails
K202086 — Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White ColorsShen Wei USA, Inc. Mar 16, 2021
K202554 — Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced HemostasisStryker Sustainability Solutions Mar 16, 2021
K210487 — MIPLNI YK-244 Disposable Surgical MaskHunan Yuankang Biological Technology Co., Ltd. Mar 16, 2021
K201924 — Single-Use Surgical MaskQiqihar Hengxin Medical Supplies, Ltd. Mar 15, 2021
K201698 — Medical Surgical MaskHangzhou Mycode Bio-Medicine Co., Ltd. Mar 15, 2021
K210193 — DB-CompositeDimensional Bioceramics, LLC Mar 15, 2021
K203382 — Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A. Mar 15, 2021
K202438 — Ensure Single-Use Coagulation ForcepsMicro-Tech (Nanjing) Co., Ltd. Mar 15, 2021
K203697 — BC Reflex Uni Knee SystemBodycad Laboratories, Inc. Mar 12, 2021
K203666 — Vinyl Examination Gloves(Yellow)Lutai Medical Technology Co., Ltd. Mar 12, 2021
K210060 — CoLink Mfx Implant SystemIn2Bones USA, LLC Mar 12, 2021
K203250 — TaiChiCOur United Corporation Mar 12, 2021
K201452 — Groshong NXT PICC CatheterC.R. Bard, Inc. Mar 12, 2021
K210526 — Medline Cautery Tip CleanerMedline Industries, Inc. Mar 12, 2021
K201617 — TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))Schoelly Fiberoptic GmbH Mar 12, 2021
K203822 — ProFound AI Software V3.0Icad, Inc. Mar 12, 2021
K203707 — Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603Shenzhen Zhengkang Technology Co., Ltd. Mar 12, 2021
K203775 — AIC disposable medical maskThe Aleen International Corporation Mar 12, 2021
K203188 — ADDH&Abyz Co., Ltd. Mar 12, 2021
K203060 — VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote ControlJohnson & Johnson Surgical Vision, Inc. Mar 12, 2021
K202284 — OncospaceOncospace, Inc. Mar 12, 2021
K192649 — Endo MotorFoshan Cicada Dental Instrument Co, Ltd. Mar 12, 2021
K201410 — VENUS Bracket, ROSE BracketGni Co., Ltd. Mar 12, 2021
K201975 — miha bodytec IIMiha Bodytec GmbH Mar 11, 2021
K210078 — Stryker ProCinch Adjustable Loop DeviceStryker Endoscopy Mar 11, 2021
K202062 — wheezo WheezeRate DetectorRespiri Limited Mar 11, 2021
K203614 — Monarch BronchoscopeAuris Health, Inc., A Johnson And Johnson Family Company Mar 11, 2021
K202443 — Smart Kit Basic, Smart Kit ProBsl Co., Ltd. Mar 11, 2021
K202961 — AquaBeam Robotic SystemProcept Biorobotics, Corporation Mar 11, 2021
K201892 — Ritleng®+ and Ritleng®+ PVPFci (France Chirurgie Instrumentation) Sas Mar 11, 2021
K210392 — WorkMate Claris SystemAbbott Mar 11, 2021
K210142 — Fiber DustQuanta System Spa Mar 11, 2021
K203606 — Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)Meris Investment Group Mar 10, 2021
K210164 — Vantage Elan 1.5T, MRT-2020, V6.0Canon Medical Systems Corporation Mar 10, 2021
K210359 — Hexanium TLIFSpinevision, S.A.S. Mar 10, 2021
K201492 — Non-Sterile Zirconia BlockBioden Co., Ltd. Mar 10, 2021
K201809 — AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber AccessoryBaxter Healthcare Corportation Mar 10, 2021
K203065 — Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. Mar 10, 2021
K203574 — HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2Hivox Biotek, Inc. Mar 10, 2021
K202411 — Surgical MaskAllmed Medical Products Co., Ltd. Mar 10, 2021
K202548 — Surgical Face MaskWanxinda (Guangzhou) Technology Product Co., Ltd. Mar 10, 2021
K202815 — PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc Mar 10, 2021
K193663 — FloPump 57mL Centrifugal PumpInternational Biophysics Corporation Mar 10, 2021
K201866 — NovaLine Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd. Mar 10, 2021
K202161 — Surgical Face MaskHunan Eexi Technology & Service Co., Ltd. Mar 10, 2021
K202891 — Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd. Mar 9, 2021
K210181 — Nordiwell Surgical Face MaskChangzhou Combat Protective Equipment Co., Ltd. Mar 9, 2021
K202409 — Surgical MaskAllmed Medical Products Co., Ltd. Mar 9, 2021
K203518 — QuicktomeOmniscient Neurotechnology Pty Ltd (O8T) Mar 9, 2021
K203618 — Neodent EasyGuide Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A. Mar 9, 2021
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