510(k) Clearances in 2021 — Page 40

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 40 of 61)
510(k) clearancesDetails
K202793 — Cercare Medical NeurosuiteCercare Medical Aps May 17, 2021
K211037 — Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation May 17, 2021
K211105 — Ear-Friendly MaskRay Co., Ltd. May 17, 2021
K210217 — Needleless ConnectorJiangsu Caina Medical Co.,Ltd May 17, 2021
K210942 — MicroFrance Monopolar and Bipolar Electrosurgical InstrumentsIntegra Microfrance May 14, 2021
K200573 — BoneTrust Mini Implant SystemMedical Instinct Deutschland GmbH May 14, 2021
K210302 — Disposable Medical maskAnhui Jbh Medical Apparatus Co., Ltd. May 14, 2021
K210417 — Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DLBio Compression Systems, Inc. May 14, 2021
K210780 — Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)Shandong Shangwei Medical Products Co., Ltd. May 14, 2021
K210072 — HOLOSCOPE-iReal View Imaging , Ltd. May 14, 2021
K211100 — AcQGuide MAX Steerable SheathAcutus Medical, Inc. May 14, 2021
K202138 — Cardiac Trigger MonitorIvy Biomedical Systems, Inc. May 14, 2021
K210200 — 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-LockSet Medikal Sanayi VE Ticaret Anonim Sirketi May 14, 2021
K202862 — Gx-IVF, Gx-TL, Gx-MOPS PLUSVitrolife Sweden AB May 14, 2021
K211130 — NPsealGuard Medical, Inc. May 14, 2021
K202747 — Klarity BolusKlarity Medical & Equipment (GZ) Co., Ltd. May 14, 2021
K203226 — TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MMRichard Wolf Medical Instruments Corporation May 14, 2021
K210774 — Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)Shandong Jieshi Medical Products Co., Ltd. May 14, 2021
K210799 — Powder Free Vinyl Patient Examination GlovesYunnan Huazhiyuan Medical Technology Co., Ltd. May 14, 2021
K210485 — PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)Pentax Of America, Inc. May 13, 2021
K211004 — GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A. May 13, 2021
K210815 — Disposable Face MaskBiobase Scientific (Shandong) Co., Ltd. May 13, 2021
K210426 — HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. May 13, 2021
K211115 — A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company May 13, 2021
K203481 — CryoVIVERecensmedical, Inc. May 13, 2021
K210874 — Reliance Spinal Screw SystemReliance Medical Systems, LLC May 13, 2021
K210369 — Powder Free Nitrile Examination GlovePastel Glove Sdn Bhd May 13, 2021
K202697 — United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure MaskUnited Sewing Automation, Inc. May 13, 2021
K200555 — Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)Prevest Denpro Limited May 13, 2021
K211118 — SIGNA 7.0TGe Medical Systems, LLC May 13, 2021
K203566 — Tablet ApplicationSmith & Nephew May 13, 2021
K202924 — LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG May 13, 2021
K210979 — PreliviaRehabtronics, Inc. May 13, 2021
K210557 — Symbia VA10A FamilySiemens Medical Solutions USA, Inc. May 12, 2021
K210737 — 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 May 12, 2021
K210974 — High Performance Antimicrobial Gelling Fiber with SilverAdvanced Medical Solutions, Ltd. May 12, 2021
K210439 — NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated May 12, 2021
K210809 — iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc. May 12, 2021
K210153 — NextAR RSA PlatformMedacta International S.A. May 12, 2021
K210435 — Automatic Arm Electronic Blood Pressure MonitorShenzhen Lepu Intelligent Medical Equipment Co., Ltd. May 12, 2021
K210689 — ClotTriever Thrombectomy SystemInari Medical, Inc. May 12, 2021
K210572 — Neurodyn V2.0, Neurodyn Aussie V2.0Ibramed Equipamentos Medicos May 11, 2021
K210967 — Air Pressure Therapy System: VU-IPC06Xiamen Weiyou Intelligent Technology Co., Ltd. May 11, 2021
K202272 — HD MediastinoscopeKarl Storz Endoscopy America, Inc. May 11, 2021
K203228 — DART-FIRE EDGE Cannulated Screw SystemWright Medical May 11, 2021
K202973 — HANAROSTENT Benefit Biliary (NNN)M.I.Tech Co., Ltd. May 11, 2021
K202860 — Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)Valley Contax, Inc. May 11, 2021
K203320 — Endo MotorGuilin Woodpecker Medical Instrument Co., Ltd. May 10, 2021
K193649 — Yumizen C1200 Creatinine PAPHORIBA ABX SAS May 10, 2021
K190737 — Solax Electric Scooter (Models: S204311M, S204161, S204143)Dongguan Prestige Sporting Goods Co., Ltd. May 10, 2021
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