510(k) Clearances in 2021 — Page 21

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 21 of 61)
510(k) clearancesDetails
K211352 — Electronic Thermometer (XHF2001, XHF2002)Putian Hanjiang Huafeng Plastic Co., Ltd. Sep 9, 2021
K210402 — Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc. Sep 9, 2021
K210509 — Rocket Platinum Cured CathterRocket Medical Plc Sep 9, 2021
K201785 — EPIEN Dental CleanserEpien Medical, Inc. Sep 9, 2021
K211832 — Fluid Resistant Procedure Mask, Fluid Resistant Surgical MaskZhejiang Lanhine Medical Products, Ltd. Sep 8, 2021
K211945 — V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Sep 8, 2021
DEN200030 — FEops HEARTguideFeops NV Sep 8, 2021
K210712 — Verifine Mechanical Safety Insulin SyringePromisemed Hangzhou Meditech Co., Ltd. Sep 8, 2021
K203555 — AmCAD-UTAmcad Biomed Corporation Sep 8, 2021
K211127 — Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DMHealth & Life Co., Ltd. Sep 8, 2021
K211597 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems Sep 8, 2021
K212495 — Leva Pelvic Health SystemRenovia, Inc. Sep 8, 2021
K203434 — BlueStar RxWelldoc, Inc. Sep 8, 2021
K211867 — RayStation 11.0RaySearch Laboratories AB (PUBL) Sep 8, 2021
K212058 — Longeviti ClearFit™ OTS Cranial ImplantsLongeviti Neuro Solutions, LLC Sep 8, 2021
K211235 — CIRCUL8 Luxe DVT Prevention DeviceOrtho8, Inc. Sep 8, 2021
K211607 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant ConcentrateSTERIS Corporation Sep 7, 2021
K211769 — OneLIF Intervertebral Body Replacement SystemNovapproach Spine Sep 7, 2021
K211579 — CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)Bolder Surgical, LLC Sep 7, 2021
K202049 — Python Catheter/Over-the-Wire Latis Graft Cleaning CatheterApplied Medical Resources Corporation Sep 7, 2021
K210997 — PreferX Delivery SystemMd3, LLC Sep 7, 2021
K202796 — SANSIN Tubing Sets for HemodialysisJiangxi Sanxin Medtec Co., Ltd. Sep 6, 2021
K212081 — 3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 12283M Company Sep 5, 2021
K211736 — Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)Shenzhen Osto Technology Company Limited Sep 5, 2021
K203536 — Male Latex CondomGlobal Protection Corp. Sep 3, 2021
K211637 — AROMA GRANDDaeju Meditech Engineering Co., Ltd. Sep 3, 2021
K210470 — C-CURVE Interbody Fusion DeviceMedicrea International SA Sep 3, 2021
K211762 — Altor Safety 4-Ply Surgical Mask (Model:62232)Altor Safety, LLC Sep 3, 2021
K201305 — Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest DrainAtrium Medical Corporation Sep 3, 2021
K210940 — LuxaPrint Ortho PlusDmg Digital Enterprises SE Sep 3, 2021
K202689 — Dentilube SprayOxy2Plus, LLC Sep 3, 2021
K210133 — Current Health Monitoring System Gen 2 (G2)Current Health Sep 3, 2021
K210342 — BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating AdaptorSTERIS Corporation Sep 3, 2021
K211583 — Infrared Thermometer, Model: HW-1Dongguan Simzo Electronic Technology Co., Ltd. Sep 3, 2021
K202786 — Dental Low-speed Handpieces and AccessoriesMicrop Technology (Taiwan), Inc. Sep 3, 2021
K212476 — KARL STORZ Flexible HD Cysto-Urethroscope SystemKarl Storz Endoscopy America, Inc. Sep 3, 2021
K210861 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)Stryker GmbH Sep 3, 2021
K212421 — ADAS 3DAdas3D Medical S.L. Sep 3, 2021
K211200 — WoundExpressHuntleigh Healthcare , Ltd. Sep 3, 2021
K211881 — AI SegmentationVarian Medical Systems, Inc. Sep 2, 2021
K212491 — Air Relax Pro Model AR-4.0Diode Art Engineering Doing Business AS Air Relax Sep 2, 2021
K211074 — Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc. Sep 2, 2021
K212494 — Lung Image AnalysisPulmonx Corporation Sep 2, 2021
K211201 — MagnetOs Easypack PuttyKuros Biosciences B.V Sep 2, 2021
K210868 — Nitrile Examination Gloves Powder Free (Blue)Great Eco Glove Sdn. Bhd. Sep 2, 2021
K203722 — RayPilot SystemMicropos Medical AB Sep 2, 2021
K211778 — Nitrile Examination Gloves, Green/ Blue/ Black ColorZhenjiang Suhui Latex Products Co., Ltd. Sep 2, 2021
K201445 — MultiCath, AcQRate Dx Fixed Curve CatheterBiotronik, Inc. Sep 2, 2021
K201612 — Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5Viramal Limited Sep 2, 2021
K210901 — Elecsys Vitamin D total IIIRoche Diagnostics Sep 1, 2021
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