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

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    SWEET DREEMS SIMULATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BEAUTIFIL II LS

    FDA 510(k)
    FDA Class 2 ·Dental

    BIOTROL-ABNORMAL

    FDA 510(k)
    FDA Class 2 ·Hematology

    CAPSURE Z

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 10, 2014

    OPTIFLUX 160NR DIALYZER FINISHED ASSEMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING·Product code FJI·December 5, 2012

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 22, 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