BEUDAMED
    8 results · 34ms · Sources: EU EUDAMED, US FDA

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    SICKLE CELL REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Hematology

    NOBLUS DIAGNOSTIC ULTRASOUND SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    PRACTIX CONVENIO

    FDA 510(k)
    FDA Class 2 ·Radiology

    NOBLUS ULTRASOUND SCANNER

    FDA Adverse Event
    Malfunction ·Product code IYO·March 30, 2017

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 1, 2014

    UPHOLD VAGINAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·November 21, 2012

    STARCLOSE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·September 18, 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