BEUDAMED
    10 results · 25ms · Sources: EU EUDAMED, US FDA

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    GINGERBREAD MAN (TM)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    AVEA VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GABBAY-FRATER SUTURE GUIDE

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

    VIASYS

    FDA Adverse Event
    Malfunction ·CAREFUSION 207, INC·Product code CBK·October 26, 2009

    ARCHITECT IVANCOMYCIN

    FDA Adverse Event
    Malfunction ·ABBOTT GERMANY·Product code LEH·October 8, 2010

    ANEURX STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·December 7, 2012

    PROTECTA XT CRT-D

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

    VIASYS

    FDA Adverse Event
    Other ·CAREFUSION 207, INC·Product code CBK·October 27, 2009

    VIASYS

    FDA Adverse Event
    Other ·CAREFUSION 207, INC.·Product code CBK·October 27, 2009

    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