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

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    GRAM STAIN CONTROL SLIDE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BELLUS SHADING KIT

    FDA 510(k)
    FDA Class 2 ·Dental

    Zygomatic Implants

    FDA 510(k)
    FDA Class 2 ·Dental

    REMANUFACTURED BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·November 1, 2010

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CRMD·Product code NVY·January 13, 2014

    ASR ACETABULAR CUPS 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·December 31, 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