BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    WELLSHIRE BASELINK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CERSA-CANE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    LIPID CONTROL PRODUCT # ACS LC 101

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    M2A-MAGNUM MOD HEAD SZ 48MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 24, 2014

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIV.·Product code FNL·October 29, 2010

    PRIMEBIG WHEEL ELECT STRETCHER

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·November 9, 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