BEUDAMED
    7 results · 28ms · Sources: EU EUDAMED, US FDA

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    MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)

    FDA 510(k)
    FDA Class 2 ·Radiology

    EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCUSET SENSOR, MODEL 2000

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

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 26, 2013

    OPTEASE VENA CAVA FILTER

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code DTK·May 9, 2011

    INJECTION GOLD PROBE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORP.·Product code KNS·July 10, 2008

    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