BEUDAMED
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    CAROTID BALLOON SHUNT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEEPVESSEL Plaque

    FDA 510(k)
    FDA Class 2 ·Radiology

    BABYAIR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 15, 2014

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·October 7, 2010

    HEARTSTART XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 5, 2012

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012