510(k) Clearances in 2021 — Page 46

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 46 of 61)
510(k) clearancesDetails
K210408 — DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC Apr 8, 2021
K210062 — Mectaplug PE IIMedacta International S.A. Apr 8, 2021
K202729 — Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH Apr 8, 2021
K203550 — ActivSight Intraoperative Imaging SystemActiv Surgical, Inc. Apr 8, 2021
K202632 — Electric wheelchair (S7204/S7205)Dongguan Prestige Sporting Goods Co., Ltd. Apr 8, 2021
K202785 — Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd. Apr 8, 2021
K203491 — PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd. Apr 7, 2021
K210182 — PANAMA™ Anterior Cervical Plate (ACP) SystemFlospine Apr 7, 2021
K210106 — Nitrile Examination GlovesZhenjiang Huayang Latex Products Co., Ltd. Apr 7, 2021
K203520 — Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC Apr 7, 2021
K200463 — Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd Apr 7, 2021
K210701 — CATALYS Precision Laser SystemAmo Manufacturing USA, LLC Apr 7, 2021
K203673 — MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)Medacta International S.A. Apr 6, 2021
K210681 — SiteSeal SVEnsite Vascular Apr 6, 2021
K210734 — Endovascular Dilator and SetsCook Incorporated Apr 6, 2021
K201457 — Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/71164 Apr 6, 2021
K210685 — AcQCross Qx Integrated Transseptal Dilator/NeedleAcutus Medical, Inc. Apr 6, 2021
K201257 — MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)Arrive Systems, Inc. Apr 6, 2021
K210716 — CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics , Ltd. Apr 6, 2021
K210554 — Physica systemLima Corporate S.P.A. Apr 6, 2021
K203801 — Disposable Surgical Face MaskAnhui Jiabao Protective Equipments Co., Ltd. Apr 6, 2021
K202703 — Vascutek Gelsoft Plus ERS Vascular GraftVascutek, Ltd. Apr 6, 2021
K203567 — Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company Apr 5, 2021
K202655 — Disposable Medical MaskDongguan Runlin Medical Supplies Technology Co., Ltd. Apr 5, 2021
K203480 — DOUBLEFLO systemHemodia Sas Apr 5, 2021
K203623 — StentBoost MobilePhilips India Limited Apr 5, 2021
K210850 — ADAS 3DAdas3D Medical S.L. Apr 5, 2021
K203499 — Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blankVatech Acucera, Inc. Apr 5, 2021
K210130 — Stockert S5 SystemLivanova Deutschland, GmbH Apr 5, 2021
K202909 — CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd. Apr 2, 2021
K203472 — KMTI Hip Replacement SystemKyocera Medical Technologies, Inc. Apr 2, 2021
K203767 — Pristine Long-Term Hemodialysis CatheterC B Bard, Inc. Apr 2, 2021
K201171 — LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc. Apr 2, 2021
K201611 — Apex Knee SystemOmnilife Science Apr 2, 2021
K202243 — SkinPen Precision SystemCrown Aesthetics Apr 2, 2021
K202183 — Porcine Mineral Collagen CompositeCollagen Matrix, Inc. Apr 2, 2021
K202447 — Medline Orbis Surgical GownMedline Industries, Inc. Apr 2, 2021
K203230 — Global Shoulder and Delta CTA systemsDepuy Lnc. Apr 2, 2021
K210275 — Polaris Spinal SystemZimmer Biomet Spine, Inc. Apr 2, 2021
K210692 — DigitalDiagnostPhilips Medical Systems Dmc GmbH Apr 2, 2021
K210023 — Surgical Face MaskGuangdong Winsun Personal Care Products Co.,Ltd Apr 2, 2021
K210251 — ClearPath Disposable IntroducerClearmind Biomedical Apr 2, 2021
K203816 — DeGen Navigated InstrumentationDegen Medical Apr 2, 2021
K210784 — Extended HA Half PinsSmith & Nephew, Inc. Apr 2, 2021
K202441 — Eclipse II with Smart Noise CancellationCarestream Health, Inc. Apr 2, 2021
K202928 — DV. TargetDeepvoxel, Inc. Apr 2, 2021
K203310 — SyneCare 1000 Deep Vein Thrombosis Prevention Therapy SystemJiangsu Synecoun Medical Technology Co., Ltd. Apr 2, 2021
DEN200038 — Gili Pro BioSensor (also known as “Gili BioSensor System”)Continuse Biometrics , Ltd. Apr 1, 2021
K210300 — VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning SystemVuesonic, LLC Apr 1, 2021
K202768 — KOSMO Femoral StemB-One Ortho, Corp. Apr 1, 2021
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