BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    RESUSCITATOR MODELS 10400/10500/10600/10700/10800

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BluePro

    FDA 510(k)
    FDA Class 2 ·Dental

    OSTIAL PRO STENT POSITIONING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADAPTA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 10, 2014

    FINELINE I

    FDA Adverse Event
    Injury ·GUIDANT ANGLETON/ST. PAUL·Product code NVN·October 8, 2010

    HEARTMATE II LVAD

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·December 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