BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    LEE-BEAD PROLACTIN (EIA)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VITEK 2 AST-YS FLUCONAZOLE

    FDA 510(k)
    FDA Class 2 ·Microbiology

    EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADVANTAGE SERIES 26

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·October 31, 2012

    CRYSTALLINE ACTIVE FIXATION

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·June 10, 2014

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FRN·June 23, 2015

    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