BEUDAMED
    8 results · 20ms · 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.

    COVERUPS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011831703000·Matrix band on rolls, [F] 0.05 x 7.00 mm, Lengt...

    SUR-FIT SYSTEM STERILE O.R. SETS

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 27, 2014

    1527736-2007-07694

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GEI·November 16, 2007

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code MTA·November 9, 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