510(k) Clearances in 2021 — Page 56

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 56 of 61)
510(k) clearancesDetails
K202605 — Standard Procedure Mask, Standard Surgical MaskJiangsu Medplus Non-Woven Manufacturer Co., Ltd. Feb 10, 2021
K203490 — FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC Feb 10, 2021
K191897 — Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)Dongguan Prestige Sporting Goods Co., Ltd. Feb 10, 2021
K200675 — Hi bebe super (Models BT-150S and BT-150L)Bistos Co., Ltd. Feb 10, 2021
K201332 — Meditech ABPM-06 (BP6)Meditech , Ltd. Feb 10, 2021
K202174 — Digital NeuroPort Biopotential Signal Processing SystemBlackrock Microsystems Feb 10, 2021
K201536 — Infrared Forehead ThermometerHangzhou Qingyuan Medical Equipment Technology Co., Ltd. Feb 10, 2021
K203513 — SLENDERTONE Evolve Abs, Type 735Bio-Medical Research, Ltd. Feb 10, 2021
K203265 — nPro Surgical MaskNp Medical, Inc. Feb 9, 2021
K210083 — Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7Penumbra, Inc. Feb 9, 2021
K203103 — Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation Feb 9, 2021
K202850 — Concerto Versa, Detachable CoilMicro Therapeutics, Inc. D/B/A Ev3 Neurovascular Feb 9, 2021
K203055 — Stryker PEEK Customized Cranial Implant KitStryker Feb 9, 2021
K201583 — SmartCT R1.0Philips Medical Systems Nederland B.V. Feb 9, 2021
K203079 — MR Conditional Sticky Pad ElectrodeRhythmlink International, LLC Feb 9, 2021
K210272 — LIAISON Anti-HAVDiaSorin, Inc. Feb 9, 2021
K203069 — HydroMIDAccess Vascular, Inc. Feb 8, 2021
K202942 — Straumann 4 mm Short ImplantsStraumann USA, LLC Feb 8, 2021
K201635 — MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health) Feb 6, 2021
K200276 — SPEAC SystemBrain Sentinel, Inc. Feb 6, 2021
K200368 — LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG Feb 5, 2021
K200320 — Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and ReloadM/S. Meril Endo Surgery Private Limited. Feb 5, 2021
K203302 — GentleWave XSonendo, Inc. Feb 5, 2021
K210054 — Cios SpinSiemens Medical Systems USA, Inc. Feb 5, 2021
K200470 — Shofu Block HC HardShofu Dental Corporation Feb 5, 2021
K203319 — SYMPHONY™ OCT SystemMedos International SARL Feb 5, 2021
DEN200018 — eXciteOSA with remote and eXciteOSA without remoteSignifier Medical Technologies Feb 5, 2021
K210055 — Cios AlphaSiemens Medical Solutions USA, Inc. Feb 5, 2021
K203475 — LimaCorporate Kirschner WireLima Corporate S.P.A. Feb 5, 2021
K203635 — Patient Monitoring CablesJkh USA, LLC Feb 5, 2021
K203334 — The Citrefix Knotless Suture AnchorAcuitive Technologies, Inc. Feb 5, 2021
K201421 — Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie OnsDukal Corporation Feb 5, 2021
K201306 — HAMILTON-C3Hamilton Medical AG Feb 5, 2021
K201324 — Antibacterial BandageJiangsu Excellence Medical Supplies Co., Ltd. Feb 5, 2021
K203290 — BonelogicDisior, Ltd. Feb 5, 2021
K203374 — X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)De Götzen S.R.L. Feb 5, 2021
K210053 — LVivo Software ApplicationDia Imaging Analysis, Ltd. Feb 5, 2021
K201121 — SphincterotomeHangzhou AGS MedTech Co., Ltd. Feb 5, 2021
K210063 — Freudenberg Surgical MaskFreudenberg Performance Materials LP Feb 5, 2021
K203588 — ELEOS™ Limb Salvage SystemOnkos Surgical Feb 5, 2021
K210036 — Carnation Ambulatory Monitor (CAM)Bardy Diagnostics, Inc. Feb 5, 2021
K203582 — QUIBIM Precision Prostate (qp-Prostate)Quibim S.L. Feb 4, 2021
K202493 — Medical Face MaskGemtier Medical (Shanghai), Inc. Feb 4, 2021
K202872 — Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd. Feb 4, 2021
K210174 — BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetBemer Int AG Feb 4, 2021
K203573 — RESPONSE Navigation InstrumentsOrthoPediatrics Corp. Feb 4, 2021
K203598 — Omnichroma Flow BulkTokuyama Dental Corporation Feb 3, 2021
K192568 — Jiajian Self-Adhesive ElectrodeWuxi Jiajian Medical Instrument Co., Ltd. Feb 3, 2021
K203420 — EcoFit® Hip SystemImplantcast GmbH Feb 3, 2021
K202151 — Smart SPACE Shoulder SystemTechmah Medical, LLC Feb 3, 2021
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