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

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    U-200 BAG

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DFV CPG COLPOSCOPE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SYSTEM, X-RAY, STATIONARY

    FDA 510(k)
    FDA Class 2 ·Radiology

    NAVISTAR® THERMOCOOL®

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code OAD·May 20, 2014

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    PINGHU WEIFENG MATERIAL TECHNOLOGY·Product code IKX·November 6, 2012

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·August 31, 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