BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    CATHETER PLUG/PROTECTOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 7, 2015

    SIEMENS ENDO-P-PROBE

    FDA 510(k)
    FDA Class 2 ·Radiology

    TUF-COAT

    FDA 510(k)
    FDA Class 2 ·Dental

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 19, 2014

    S-ROM*SLEEVE PRX ZTT, 16B-LRG

    FDA Adverse Event
    Injury ·DEPUY IRELAND 9616671·Product code LPH·January 4, 2013

    INTEGRATED APD SET W/CASSETTE3-PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 11, 2010

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 11, 2014

    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