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

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    PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS

    FDA 510(k)
    FDA Class 2 ·Hematology

    XN-L CHECK

    FDA 510(k)
    FDA Class 2 ·Hematology

    ENZYME IMMUNOASSAY, VANCOMYCIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    COBAS INTEGRA CALCIUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CIC·October 7, 2010

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·December 5, 2012

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC INC.·Product code KRG·June 10, 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