BEUDAMED
    9 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.

    FLEXERCYCLE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ERA Implant Abutment Std 0 Deg, 2mm Cuff (AE)

    FDA UDI
    STERNGOLD DENTAL LLC·00841549113918·ERA abutments provide a resilient attachment wi...

    Swish™ Straight Abutment

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307116424·

    ISOTRON 220

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·January 9, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 22, 2010

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·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