BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    ANTELOPE BRAND PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MAM TWISTER

    FDA 510(k)
    FDA Class 2 ·Dental

    UroLift System Procedure Kit Sterilization Tray

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ASR UNI FEMORAL IMPL SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·June 24, 2014

    MEDTRONCI INFUSE BONE GRAFT OR RHBMP2

    FDA Adverse Event
    Injury ·MEDTORNIC, INC.·Product code NEK·December 26, 2012

    BLAKE DRAIN

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code KOG·November 3, 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