BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    HORSE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATED

    FDA 510(k)
    FDA Class 1 ·Hematology

    LIGHTSPEED 7.1 CT SCANNER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Tina-quant Cystatin C Gen.2

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 28, 2014

    ATTAIN OTW

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 8, 2010

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·November 8, 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