BEUDAMED
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    CADIO-RESPIRATORY MONITOR #CR-2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MONDEAL

    FDA UDI
    MONDEAL Medical Systems GmbH·04050435116650·MCD Screw 2.3 x 12 mm cannulated M1 partia...

    MICROMEDIC AUTOMATIC COMPUTING CENTER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CONTROL PLASMA P

    FDA 510(k)
    FDA Class 2 ·Hematology

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·February 27, 2014

    CLARIFLEX

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·November 7, 2012

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·August 30, 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