BEUDAMED
    7 results · 23ms · 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.

    CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MONOCLONAL ANTIBODY ANTI-CD3

    FDA 510(k)
    FDA Class 2 ·Hematology

    CURAPULS 403 DIATHERMY UNIT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 9, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·November 15, 2010

    WALLFLEX? COLONIC

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code MQR·July 1, 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