BEUDAMED
    7 results · 17ms · 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.

    DIAZO, COLORIMETRIC BILIRUBIN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SIEMENS-ELEMA AB CO2 MONITOR 130

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ACRYDERM ABSORBENT OXYGEN DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 18, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·October 21, 2010

    WAVESCAN WAVEFRONT SYSTEM WS1

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code HKO·December 20, 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