BEUDAMED
    7 results · 21ms · 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.

    FLEXIBLE ENDOSCOPIC ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ENDOSCOPIC HEMOSTATIC LIGATING LOOP

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDI LISS DENTAL ANALGESIA DEVICE (SBL601)

    FDA 510(k)
    FDA Unclassified ·Unknown

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·January 9, 2013

    PULSE GEN MODEL 103

    FDA Adverse Event
    Death ·CYBERONICS INC·Product code LYJ·November 19, 2010

    INSIGNIA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2014

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF 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