510(k) Clearances in 2021 — Page 31

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 31 of 61)
510(k) clearancesDetails
K210666 — Chest-CADImagen Technologies, Inc. Jul 20, 2021
K203765 — ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-TrayZirkonzahn Srl Jul 20, 2021
K210349 — TKO Composite Bite Turbo GelReliance Orthodontic Products, Inc. Jul 20, 2021
K203168 — LifeLens Wireless ECG MonitorLifeLens Technologies, Inc. Jul 20, 2021
K210877 — Evolve System with the T3 ApplicatorInMode , Ltd. Jul 19, 2021
K211910 — Z-6 Atrioseptostomy CatheterNuMED, Inc. Jul 19, 2021
K210963 — ENNOVATE Spinal SystemAesculap Implant Systems, LLC Jul 19, 2021
K201147 — Elos® Intramedullary Nailing SystemIntrauma S.P.A Jul 19, 2021
K211188 — xvision Spine system (XVS)Augmedics, Ltd. Jul 19, 2021
K211548 — POLARSTEM Calcar Reamer GuideSmith & Nephew, Inc. Jul 19, 2021
K211291 — Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DFiagon GmbH Jul 19, 2021
K211239 — Vinyl Patient Examination GlovesJiangxi Shengda Medical Technology Co., Ltd. Jul 17, 2021
K211177 — Powder Free Vinyl Patient Examination GlovesShijiazhuang Hongjun Plastic Manufacture Co., Ltd. Jul 17, 2021
K210103 — SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIXLifelong Meditech Private Limited Jul 16, 2021
K203108 — Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC Jul 16, 2021
K211792 — StitchKitOrigami Surgical Inc . Jul 16, 2021
K210544 — Medtronic Extended infusion setUnomedical A/S Jul 16, 2021
K210186 — PacBond OnePac-Dent, Inc. Jul 16, 2021
K210761 — Velguard Surgical Face MaskEsstee Exports Health Care Division Jul 16, 2021
K201473 — ExoAtlet-IIExoatlet Asia Co. , Ltd. Jul 16, 2021
K211946 — Soniquence Reusable Bipolar CableSoniquence, LLC Jul 16, 2021
K210011 — JS Dental Lab Mouth GuardAmpower Dental Laboratories, LLC Jul 16, 2021
K193397 — ADVIA Centaur® Digoxin assaySiemens Healthcare Diagnostics, Inc. Jul 16, 2021
K211111 — SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc. Jul 16, 2021
K211592 — Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc. Jul 16, 2021
K211525 — SwiftNINJA Steerable MicrocatheterMerit Medical Systems, Inc. Jul 16, 2021
K203435 — Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring SystemNihon Kohden Corporation Jul 16, 2021
K210750 — Acumed Clavicle Hook Plating SystemAcumed, LLC Jul 15, 2021
K201328 — Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. Jul 15, 2021
K211042 — Disposable Procedural Ear-loop Face MaskChangzhou Dsb Medical Co., Ltd. Jul 15, 2021
K202846 — TERA HARZGraphy, Inc. Jul 15, 2021
K211933 — EleVation Breast Biopsy SystemBard Peripheral Vascular Jul 15, 2021
K201100 — Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. Jul 15, 2021
K211547 — Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)Edma Group, LLC Jul 15, 2021
K211514 — Longeviti PorousFit implantLongeviti Neuro Solutions, LLC Jul 15, 2021
K210431 — ReCrossImds Operations B.V. Jul 15, 2021
K202638 — Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd. Jul 15, 2021
K200096 — Crosstex VH2O2 Chemical IndicatorsCrosstex International, Inc. (A Cantel Medical Company) Jul 15, 2021
K202390 — Aduro Light Beauty MaskShenzhen Kaiyan Medical CO , Ltd. Jul 14, 2021
K201733 — Provident II Hip StemsGlobus Medical, Inc. Jul 14, 2021
K211866 — Bencox THR SystemCorentec Co., Ltd. Jul 14, 2021
K200983 — Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty MachineNingbo Hesi Electric Co., Ltd. Jul 14, 2021
K203509 — SMART FINDERIms Giotto S.P.A. Jul 14, 2021
K202918 — OsteoSync™ Ti Dental MeshSites Medical, LLC Jul 14, 2021
K203728 — DarwinLuvo Medical Technologies, Inc. Jul 14, 2021
K203023 — Pisces Spinal SystemOrtho Development Corporation Jul 14, 2021
K193047 — N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH Jul 14, 2021
K203496 — Nexo-Gide Bilayer Collagen MembraneGeistlich Pharma AG Jul 14, 2021
K203115 — ARVIS Surgical Navigation SystemInsight Medical Systems, Inc. Jul 14, 2021
K202067 — EliA SmDP-SPhadia AB Jul 14, 2021
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