BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    EXACTECH TOTAL HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Truscope Ultra Patient Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO DIADEXUS PLAC TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    HOMECHOICE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - LARGO·Product code FKX·December 7, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALHTCARE CORP·Product code FRN·January 23, 2014

    DISCOVERY II

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 8, 2010

    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