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

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    VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    COULTER 5C CELL CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    Opticage(R) Expandable Interbody Fusion Device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 15, 2014

    GENDER SOLUTIONS N-K FLEX ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code MBH·December 5, 2012

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·September 27, 2010

    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