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

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    SONY VIDEO GRAPHIC PRINTER UP-850

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    COAGULATION ARP

    FDA 510(k)
    FDA Class 2 ·Hematology

    MONOBOND PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    SYNVISC

    FDA Adverse Event
    Injury ·GENZYME BIOSURGERY·Product code MOZ·June 4, 2014

    ABBOTT AXSYM SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·December 31, 2012

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·October 28, 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