BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    GEN-PROBE MYCOPLASMA PNEUMONIA RAPID DETECT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    K3PRO SURGICAL TRAY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TOTAL BILIRUBIN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INSYNC III PROTECT

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NIK·June 10, 2014

    AMPLATZER® SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·October 7, 2010

    SPRINTER RX

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code LOX·December 6, 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