BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    ORTHO* ALTERNATIVE PATHWAY COMPL. TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    Ortho Device, ADAPTIX 3D Orthopedic Imaging System

    FDA 510(k)
    FDA Class 2 ·Radiology

    FULCRUM

    FDA 510(k)
    FDA Class 2 ·Radiology

    M2A-MAGNUM PF CUP 54ODX48ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 20, 2014

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·October 1, 2012

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·September 1, 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