510(k) Clearances in 2021 — Page 29

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 29 of 61)
510(k) clearancesDetails
K210409 — Disposable Surgical Face MaskShandong Zhushi Pharmaceutical Group Co., Ltd. Jul 28, 2021
K201657 — Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic HeadsCorin, Ltd. Jul 28, 2021
K211677 — ELEOS Limb Salvage SystemOnkos Surgical Jul 28, 2021
K211395 — NIO-IEinstein Works, LLC Jul 28, 2021
K211875 — Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe Aps Jul 28, 2021
K211839 — Electrode Market Disposable Surface ElectrodesElectrode Market Co., Ltd. Jul 28, 2021
K211861 — TAIJI Professional Series Level 3 Surgical Face MaskTaiji Medical Supplies, Inc. Jul 28, 2021
K211335 — Diode Laser Machine, Model Number: BM-100Zhengzhou Bestview ST Co., Ltd. Jul 28, 2021
K211225 — MIS Ti-base abutmentDentsply Sirona Jul 28, 2021
K211014 — PortraySurround Medical Systems Jul 28, 2021
K211994 — Braun Silk.expert MiniCyden Limited Jul 28, 2021
K203359 — BD Flu+ SyringeBecton, Dickinson And Company Jul 28, 2021
K211497 — Surgical MaskHoneywell Safety Products Jul 28, 2021
K211129 — Neocis Guidance System (NGS) with Intraoral Fiducial ArrayNeocis, Inc. Jul 28, 2021
K211646 — FINE OsteotomyBodycad Laboratories, Inc. Jul 28, 2021
K210189 — Pac-Dent Denture Base ResinPac-Dent, Inc. Jul 28, 2021
K210856 — Purism Disposable Surgical MaskChuzhou Daddy'S Choice Science And Technology Co., Ltd. Jul 28, 2021
K211874 — Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe Aps Jul 28, 2021
K211247 — PET VCARGE Medical Systems SCS Jul 27, 2021
K212074 — ClariCT.AIClaripi, Inc. Jul 27, 2021
K211325 — Senhance Surgical SystemAsensus Surgical, Inc. Jul 27, 2021
K211989 — Aveir IntroducerABBOTT MEDICAL Jul 27, 2021
K210736 — doctorgram Stethoscope DES-IGv Concepts Jul 27, 2021
K211279 — Volpara Imaging SoftwareVolpara Health Technologies Limited Jul 27, 2021
K211655 — aPROMISEExini Diagnostics AB Jul 27, 2021
K210664 — DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)Ra Medical Systems,Inc Jul 27, 2021
K210469 — Insight Agile DRFImaging Engineering, LLC Jul 27, 2021
K211990 — Rist 071 Radial Access Guide CatheterMicro Therapeutics, Inc. D/B/A Ev3 Neurovascular Jul 27, 2021
K210635 — Route 92 Medical Full Length 088 Access SystemRoute 92 Medical, Inc. Jul 27, 2021
K201326 — Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in HairPsychemedics Corporation Jul 27, 2021
K210884 — 1Derful HS, 1Derful HT1Derful, Inc. Jul 27, 2021
K210791 — Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai Jul 27, 2021
K211932 — Fixxsure Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC Jul 27, 2021
K210016 — Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS SystemIntegra LifeSciences Corporation Jul 27, 2021
K210477 — AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc. Jul 26, 2021
K211643 — Vision Monitor - MonpackONEMetrovision Jul 26, 2021
K200129 — OncoMate MSI Dx Analysis SystemPromega Corporation Jul 26, 2021
K210412 — Pac-Dent Ceramic Nanohybrid ResinPac-Dent, Inc. Jul 26, 2021
K211984 — MASC Surgical MaskMid-America Safety Corp. Jul 25, 2021
K211262 — Disposable Vinyl Nitrile Synthetic Gloves Powder FreeTangshan Hongyun Healthcare Products Co., Ltd. Jul 24, 2021
K211363 — Medical Face MaskHubei Kangning Protective Products Co., Ltd. Jul 24, 2021
K202296 — Infrared Forehead Thermometer, Model BSX976Shenzhen Bsx Technology Electronics Co., Ltd. Jul 23, 2021
K212030 — Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower Jul 23, 2021
K211386 — MySpine WebPlanner & MyBalanceMedacta International S.A. Jul 23, 2021
K212052 — HMB32 Dialysis SolutionHaemopharm Biofluids S.R.L. Jul 23, 2021
K210903 — IS Multi Unit Abutment SystemNeobiotech Co., Ltd. Jul 23, 2021
K202060 — Disposable IV catheterShinva Ande Healthcare Apparatus Co., Ltd. Jul 23, 2021
K210311 — Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7.Shenzhen Mismon Technology Co., Ltd. Jul 23, 2021
K201265 — Disposable Microwave Therapeutic AntennasNanjing Eco Microwave System Co., Ltd. Jul 23, 2021
K210185 — CardioCurve Steerable SheathTalon Surgical Jul 23, 2021
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