BEUDAMED
    7 results · 26ms · 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.

    BACTEROIDES BILE ESCULIN GAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 30, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 21, 2012

    OBWEGESER SPLITT OSTEOTOME, 8MM, 22CM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code LXH·September 20, 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