BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    PACER R 9 TREADMILL

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707035787·WEB I MOL BANDS G8424-33+G2820-00 UL 32

    KY Grosz Liquid

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 24, 2014

    FOOTSWITCH 1895410 XPS SINGLE FUNCTION

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ERL·January 2, 2013

    XIA ROD DIA 6 X 400

    FDA Adverse Event
    Injury ·STRYKER SPINE BORDEAUX·Product code NKB·October 28, 2010

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012