BEUDAMED
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    HARTMAN FORCEPS STRAIGHT 3 1/2

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

    HERMES MEDICAL IMAGING SUITE V5.2

    FDA 510(k)
    FDA Class 2 ·Radiology

    EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE

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

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 28, 2014

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·November 6, 2012

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·August 26, 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