510(k) Clearances in 2021 — Page 6

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 6 of 61)
510(k) clearancesDetails
K212639 — Disposable Medical Nitrile Examination Gloves (Non sterile)Jiangsu Nanfang Medical Co., Ltd. Dec 8, 2021
K212075 — ShurFit Lumbar Interbody SystemPrecision Spine, Inc. Dec 8, 2021
K212524 — Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. Dec 8, 2021
K210817 — C&B 5.0 HybridArum Dentistry Co., Ltd. Dec 8, 2021
K212573 — PicoLO PremiumLaseroptek Co., Ltd. Dec 8, 2021
K213156 — BD Nano 2nd Gen Pen NeedleBecton, Dickinson And Company Dec 8, 2021
K211487 — MAF GuardMaf Clothing Pvt Ltd Unit-3 Dec 8, 2021
K211898 — ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20Asahi Intecc Co., Ltd. Dec 8, 2021
K213303 — Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42Infraredx, Inc. Dec 7, 2021
K212302 — BAYLAB 3-Ply Surgical Mask (BEACON I)Baylab USA, LLC Dec 7, 2021
K213512 — DERMABOND PRINEO Skin Closure SystemETHICON, Inc. Dec 7, 2021
K211309 — endomina systemEndo Tools Therapeutics S.A. Dec 7, 2021
K212438 — ComfortproThai Rubber Industry Company Limited Dec 7, 2021
K212235 — Surgical Face MaskShanghai Yunqing Industrial Co., Ltd. Dec 6, 2021
K212827 — Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugsJr Engineering & Medical Technologies (M) Sdn. Bhd. Dec 6, 2021
K213115 — CHENA-C Spacer SystemKahtnu Surgical, Inc. Dec 6, 2021
K213096 — Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc. Dec 6, 2021
K211804 — 3Delta CrownDeltamed GmbH Dec 6, 2021
K211772 — PMW01 Procedure Mask Level 1Defender Safety, Inc. Dec 6, 2021
K212548 — LUXEN CL Dental LiquidDentalmax Co., Ltd. Dec 6, 2021
K212381 — VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. Dec 6, 2021
K212852 — Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd. Dec 6, 2021
K211448 — Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact LensesPegavision Corporation Dec 6, 2021
K211561 — INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)Covidien, LLC Dec 5, 2021
K212535 — Nitrile Powder Free Blue Examination Gloves, Non-SterileMah Sing Healthcare Sdn. Bhd. Dec 4, 2021
K212219 — AHI SystemFifth Eye, Inc. Dec 3, 2021
K212258 — Medline Cardiovascular Procedure KitMedline Industries, Inc. Dec 3, 2021
K213580 — Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc. Dec 3, 2021
K210916 — PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co. Dec 3, 2021
K211786 — Independent Corneal Viewing Chamber (IVC-21)Bausch + Lomb, Incorporated Dec 3, 2021
K213116 — Everyway Incontinence Stimulation SystemEveryway Medical Instruments Co.,Ltd Dec 3, 2021
K201435 — Molecular Flow SimulationsTherataxis, LLC Dec 3, 2021
K213266 — Inspan ScrewLES Fusion SystemLespine Innovations, LLC Dec 3, 2021
K212442 — Cydar EV (Series B) and Cydar EV MapsCydar , Ltd. Dec 3, 2021
K212807 — Surgical MasksWeihai Hongyu Nonwoven Fabric Products Co., Ltd. Dec 3, 2021
K210126 — Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%The Ritedose Corporation Dec 3, 2021
DEN200005 — Klox Biophotonic LumiHeal SystemKlox Technlogies, Inc. Dec 3, 2021
K210241 — ImplaStationProdigident, Inc. Dec 3, 2021
K212500 — ArtiSential TrocarLivsmed, Inc. Dec 3, 2021
K212295 — 21HQ513DLg Electronics.Inc Dec 3, 2021
K213067 — Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. Dec 3, 2021
K212907 — Aimanfun Lumea Comfort, A-2789/A-3588Kam Yuen Plastic Products , Ltd. Dec 2, 2021
K203745 — AURORA Evacuator +CoagRebound Therapeutics Dec 2, 2021
K211452 — EncevisAustrian Institute Of Technology GmbH Dec 2, 2021
K211773 — Single-use Surgical MaskTaiwan Seafood And Fish Corporation Dec 2, 2021
K212740 — Puravita Medical Fold Flat Surgical MaskPuravita M, LLC Dec 2, 2021
K212578 — Nitrile disposable examination glovesXingyu Medical Tech Co., Ltd. Dec 2, 2021
K212802 — powder free nitrile examination glove - white, non-sterileHong Seng Gloves Sdn Bhd Dec 2, 2021
K212950 — FUJIFILM Video Laparoscope EL-R740M30Fujifilm Corporaton Dec 2, 2021
K211721 — PS SystemInter-Med, Inc. Dec 2, 2021
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