BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    OXALATE URINE CONTROLS NORMAL & ELEVAT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment

    FDA 510(k)
    FDA Class 2 ·Dental

    Puritan OptiTranz Liquid Stuart Collection and Transport System

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·June 1, 2014

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·November 9, 2012

    MODIFICATION TO CONTOUR POLARIS URETERAL STENT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code FAD·September 23, 2010

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017