BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    VARIABLE HEIGHT TRANSFER CHAIR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PASS LP SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GC FUSION

    FDA 510(k)
    FDA Class 2 ·Dental

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 30, 2014

    TI VECTRA PLATE 2 LEVEL/36MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code KWQ·October 23, 2012

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·September 14, 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