510(k) Clearances in 2021 — Page 12

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 12 of 61)
510(k) clearancesDetails
K212199 — ASAP Aspiration Catheter, ASAPLP Aspiration CatheterMerit Medical Systems, Inc. Nov 3, 2021
K211544 — Trajectory Planning, Elements Trajectory Planning, Elements Lead LocalizationBrainlab AG Nov 3, 2021
K191964 — BD Kiestra IdentifABecton, Dickinson And Company Nov 3, 2021
K212084 — Fetal DopplerShenzhen Mericonn Technology Co., Ltd. Nov 3, 2021
K203372 — SyMRISyntheticmr AB Nov 3, 2021
K212151 — FLUME catheterThe Flume Catheter Company, Ltd. Nov 3, 2021
K210777 — Powder Free Nitrile Patient Examination Gloves, Blue ColorShandong Jieshi Medical Products Co., Ltd. Nov 2, 2021
K210921 — TaiChiBOur United Corporation Nov 2, 2021
K210598 — Pediatric Nasogastric Feeding Tubes - Single ENFit PortCair Lgl Nov 2, 2021
K213326 — VisionX 3.0Durr Dental SE Nov 2, 2021
K210222 — Disposable Medical MaskGuangdong Lide Medical Technology Co., Ltd. Nov 2, 2021
K210473 — Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)Imicryl Dis Malzemeleri Sanayi VE Ticaret AS Nov 2, 2021
K212306 — Tapestry Biointegrative ImplantEmbody, Inc. Nov 2, 2021
K212948 — Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)Guangzhou Xinbo Electronic Co., Ltd. Nov 1, 2021
K212338 — SterileRight sterilization pouch and rollSterileright Packaging Mfg., Inc. Nov 1, 2021
K210499 — Alpha Dent Implants Dental Implants SystemAlpha Dent Implants GmbH Nov 1, 2021
K211586 — Nitrile Examination Gloves (Blue, Violet)Lyncmed Medical Technology (Beijing) Co., Ltd. Nov 1, 2021
K212823 — DePuy CONDUIT LLIF Angled InsertersEnztec Limited Nov 1, 2021
K212171 — Electronic Blood Pressure MonitorDongguan Kangweile Electronic Technology Co., Ltd. Nov 1, 2021
K211079 — BioFire COVID-19 Test 2Biofire Defense, LLC Nov 1, 2021
K210588 — Black Nitrile Powder Free Patient Examination Glove, Non SterileOnetexx Sdn Bhd Oct 31, 2021
K212403 — Tracheal Stent System (Y-Shaped)Micro-Tech (Nanjing) Co., Ltd. Oct 30, 2021
K211987 — ATEC Alignment AppAlphatec Spine, Inc. Oct 29, 2021
K213163 — VersaWrapAlafair Biosciences, Inc. Oct 29, 2021
K213195 — Balloon BS-3Fujifilm Corporation Oct 29, 2021
K213264 — CARTO 3 EP Navigation System Version 7.2Biosense Webster, Inc. Oct 29, 2021
K212831 — MectaLIF ExtensionMedacta International S.A. Oct 29, 2021
K212389 — Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC Oct 29, 2021
K212308 — SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder FreeSrirungruang Global Co., Ltd. Oct 29, 2021
K201032 — Phoenix Digital ThermometerPhoenix Innovative Healthcare Manufacturers Pvt. , Ltd. Oct 29, 2021
K210279 — Enbio SEnbio Group AG Oct 29, 2021
K211161 — Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC Oct 29, 2021
K210570 — TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC Oct 29, 2021
K213351 — ds Head 32ch 3.0TInvivo Corporation (Business Trade Name: Philips) Oct 29, 2021
K201496 — N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH Oct 29, 2021
K211064 — nView s1 with nav optionNview Medical Oct 29, 2021
K211019 — Disposable Monopolar Laparoscopic Tips and Reusable HandlesDannik, LLC Oct 28, 2021
K211797 — TRACKER Plus Kyphoplasty SystemGS Medical Co., Ltd. Oct 28, 2021
K212489 — BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA Oct 28, 2021
K210287 — VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)bioMerieux, Inc. Oct 28, 2021
K211581 — Disposable Nitrile Examination Gloves (Powder free, Blue)Leping Shengde Medical Technology Company Limited Oct 28, 2021
K212290 — Examination gloves -Type C (Nitrile gloves)Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. Oct 28, 2021
K211160 — EndoTool SubQ 2.1Monarch Medical Technologies, LLC Oct 28, 2021
K212424 — AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam SterilizersSTERIS Corporation Oct 28, 2021
K200839 — APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis ModuleClever Culture Systems Oct 28, 2021
K201520 — The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc. Oct 27, 2021
K203316 — V.A.C.ULTA Negative Pressure Wound Therapy SystemKci, A Part Of 3M Health Care Business Group Oct 27, 2021
K213125 — PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP TechnologySynovis Life Technologies. Inc. (A Subsidiary Of Baxter Oct 27, 2021
K211604 — Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy DrugsShanxi Hongjin Plastic Technology Co., Ltd. Oct 27, 2021
K213153 — SPIWay Endonasal Access GuideSpiway, LLC Oct 27, 2021
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