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

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    STOCKERT-SHILEY HEATER/COOLER TEMPERATURE CONTROL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAT-A-KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VELSCOPE

    FDA 510(k)
    FDA Class 2 ·Dental

    MW5072527

    FDA Adverse Event
    Injury ·September 29, 2017

    SPECTRAX SX

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·October 7, 2010

    POLARIS¿ ULTRA

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FAD·December 6, 2012

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 14, 2014

    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