BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    ULTIMA WHEELCHAIR CUSHION

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    FORZA

    FDA UDI
    Orthofix US LLC·18257200078288·PITUITARY, UP, 4MM

    POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ExcelsiusGPS

    FDA 510(k)
    FDA Class 2 ·Neurology

    ACCUSOL

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - CASTLEBAR·Product code KPO·June 24, 2014

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·October 29, 2010

    VERSATILE RANGE FILL COIL (VFC)

    FDA Adverse Event
    Injury ·MICROVENTION, INC.·Product code HCG·December 21, 2012

    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