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20+ devices

FDA 510(k) incl. De Novo Clear all

  • Sway System (Sports Plus) Ref K262000

    Sway Medical, Inc.,United States
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Lilium one (USM330) Ref K260605

    Lilium Otsuka Co., Ltd.,Japan(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Amber Arte Ref K262523

    Hass Corp.,South Korea
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Small Diameter Core Wire (CMAN-000-00) Ref K260168

    Skycade Med Corporation,FDA registration: United States
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Restrata Ref K261245

    Acera Surgical Inc,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:—

  • AVIEW Aorta Metrics Ref K260391

    Coreline Soft Co., Ltd.,South Korea
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • MODO DUO Electric Pump (B11621) Ref K261782

    TOMY International, Inc.,FDA registration: United States
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Carecube Negative Pressure Isolation Chamber (1BY) Ref K260180

    Carecubes, Inc.,FDA registration: United States
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • BD Vacutainer® Serum Blood Collection Tubes Ref K252344

    Becton, Dickinson and Company,United States
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Endox High Level Disinfectant Ref K254094

    Whiteley USA, Inc.,FDA registration: United States
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sensinel Cardiopulmonary Management (CPM) System Ref K260801

    Analog Devices, Inc.,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • TMINI Miniature Robotic System Ref K263234

    Think Surgical Inc.,FDA registration: United States
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Kim Blue Ref K262284

    Desarrollo e Investigación Médica Aragonesa S.L.,Spain
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Endox Test Strips Ref K263267

    IBT Scientific,FDA registration: United States
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set Ref K263266

    Route 92 Medical, Inc.,United States
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Disposable Manual Resuscitator (NPVC-001) Ref K263254

    Xiamen Compower Medical Tech. Co., Ltd.,China
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Diagnostic Ultrasound System (Nuewa A20W) Ref K261585

    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.,China
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • cCeLL - In vivo Ref K260315

    VPIX Medical, Inc.,South Korea
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Wireless TENS&EMS&NMES Heating Stimulator (SM9086) Ref K261574

    Hong Qiangxing (Shenzhen) Electronics Limited,China(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens Ref K262941

    Bausch & Lomb, Inc.,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:II