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

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    AMEDA HAND BREAST PUMP

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ULTRA HIGH PRESSURE INJECTOR LINES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·May 21, 2014

    SCRDRIVER T8 SELF-HOLD ANGL W/SLEEVE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXX·October 9, 2012

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·August 27, 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