510(k) Clearances in 2021 — Page 28

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 28 of 61)
510(k) clearancesDetails
K210521 — DEXA-C Cervical Interbody SystemAurora Spine, Inc. Aug 2, 2021
K211431 — breastscape v1.0Olea Medical Aug 2, 2021
K203542 — Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A. Aug 2, 2021
K211182 — H2H Powder Free Examination Blue GloveNtl Innovation Co., Ltd. Aug 1, 2021
K210768 — Wrist Blood Pressure Monitor, Blood Pressure MonitorAndon Health Co, Ltd. Jul 30, 2021
K211379 — syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. Jul 30, 2021
K203408 — Summit Patella Plating SystemEndeavor Orthopaedics, LLC Jul 30, 2021
K200770 — Mini PCNL-SystemTrokamed GmbH Jul 30, 2021
K211222 — qER-QuantQure.Ai Technologies Jul 30, 2021
K210691 — Disposable Nitrile Medical Examination GloveJiangsu Cureguard Glove Co., Ltd. Jul 30, 2021
K210870 — MEO Med Disposable Medical Face MaskFujian Meo Medical Technology Limited Jul 30, 2021
K203700 — Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30Oxoid Limited (Part Of Thermo Fisher Scientific) Jul 30, 2021
K211402 — Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd. Jul 30, 2021
K210274 — Fingertip Pulse OximeterZhuhai Linte Medical Instrument Co., Ltd. Jul 30, 2021
K211492 — Pounce Thrombectomy SystemSurmodics,Inc. Jul 30, 2021
K211761 — UltraLase Flexible CO2 Laser WaveguideW & R Investments, LLC Dba Laser Engineering Jul 30, 2021
K211790 — DX-D Imaging Package with XD DetectorsAgfa N.V. Jul 30, 2021
K203796 — Firefly Needleless ConnectorPuracath Medical, Inc. Jul 30, 2021
K202208 — BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie Bvba Jul 30, 2021
K210248 — Lab Bag with Fabric PouchAdvanced Medical Design Co., Ltd. Jul 30, 2021
K210938 — PowerDot PD-01MT2 Muscle StimulatorSmartmissimo Technologies Pte, Ltd. Jul 30, 2021
K210154 — Labat series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co. , Ltd. Jul 30, 2021
K211380 — ElexirNu Eyne Co., Ltd. Jul 30, 2021
K211264 — Disposable Nitrile Examination GlovesShenzhen Shiqiao Science And Technology Co., Ltd. Jul 30, 2021
K211338 — EMBOTRAP III Revascularization DeviceNeuravi, Ltd. Jul 30, 2021
K211710 — Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion SystemOrthofix, Inc. Jul 30, 2021
K201761 — FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)Abbott Diabetes Care, Inc. Jul 30, 2021
K210264 — BD PowerPiCC CatheterBard Access Systems, Inc. Jul 30, 2021
K212035 — FibroScan 230Echosens Jul 30, 2021
K203224 — Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC Jul 30, 2021
K202780 — SectumNeauvia North America Jul 30, 2021
K211314 — OCS Lung SolutionTransMedics, Inc. Jul 29, 2021
K210953 — SMART Taylor Spatial FrameSmith & Nephew, Inc. Jul 29, 2021
K210770 — Arm Blood Pressure Monitor, Wireless Blood Pressure MonitorAndon Health Co, Ltd. Jul 29, 2021
K211131 — Disposable Nitrile Medical Examination GloveSiyang Threeguard Medical Supplies Co., Ltd. Jul 29, 2021
K203753 — Straumann Surgical CassettesStraumann USA, LLC Jul 29, 2021
K211664 — GMK Sphere RevisionMedacta International S.A. Jul 29, 2021
K210115 — FiteBac CC OrthoSealLargent Health, LLC Jul 29, 2021
K211317 — CRUXVIEWCruxell Corp. Jul 29, 2021
K210862 — Hemafuse SystemSisu Global Health Jul 29, 2021
K211341 — Blue Nitrile Exam GlovesJiangxi Surefine Medical Co., Ltd. Jul 29, 2021
K210574 — NuVasive Pulse SystemNu Vasive, Incorporated Jul 29, 2021
K211229 — Vinyl compound examination glovesHebei Titans Hongsen Medical Technology Co., Ltd. Jul 29, 2021
K211663 — Zap-X Radiosurgical SystemZap Surgical Systems, Inc. Jul 29, 2021
K202825 — BTI Extra-Short Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. Jul 29, 2021
K211991 — Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. Jul 28, 2021
K203431 — Disposable Ear Thermometer Probe CoverHuaian Zhongxin Packing Material Co., Ltd. Jul 28, 2021
K211455 — Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White ColorsShen Wei USA, Inc. Jul 28, 2021
K211489 — Dental Impression MaterialNanchang Dental Bright Technology Co., Ltd. Jul 28, 2021
K210379 — Broncho Videoscope SystemScivita Medical Technology Co., Ltd. Jul 28, 2021
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