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

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    RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Echo Large Bore Introducer Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BC-5D Hematology Control

    FDA 510(k)
    FDA Class 2 ·Hematology

    PLUM XLM W/MODIFD B

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 15, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 7, 2010

    VASO VIEW HEMOPRO

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·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