BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    COVER LIMB

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    EBI XFIX DFS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MYOVISION 3.0 WIREFREE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    840 VENT USA

    FDA Adverse Event
    Malfunction ·THE COVIDIEN TECHNICAL·Product code CBK·February 19, 2014

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·November 7, 2012

    OPTI-FREE REPLENISH

    FDA Adverse Event
    Injury ·ALCON - FORT WORTH / ALCON LABORATORIES, INC.·Product code LPN·August 25, 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