BEUDAMED
    7 results · 43ms · Sources: EU EUDAMED, US FDA

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    PLASTIC BRACKETS

    FDA 510(k)
    FDA Class 2 ·Dental

    DESERET SUBCLAVIAN JUGULAR CATH. SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INFUSART

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ST. JUDE AGILIS NXT

    FDA Adverse Event
    Malfunction ·ST. JUDE·Product code DYB·June 11, 2014

    INRATIO

    FDA Adverse Event
    Other ·ALERE SAN DIEGO, INC·Product code GJS·October 12, 2010

    T-PAL SPACER APPLICATOR HANDLE

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code LXH·December 14, 2012

    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