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

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    FLOW DIRECTED THERMODILUTION CATH W/VEN

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADROIT Guiding Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO: VIEWSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 15, 2012

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 14, 2014

    FORTIFY ASSURA DR ICD, US

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC. (CRM-KISTA)·Product code LWS·June 15, 2015

    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