BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EndoFLIP

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

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·June 10, 2014

    TC SP02RT

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·October 29, 2012

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 22, 2015

    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