BEUDAMED
    11 results · 26ms · Sources: EU EUDAMED, US FDA

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    LIFEMED LIFECOIL CATHETERS

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

    BANANA KNIFE - K841969-LABELING

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

    CAMELBACK HANDLE-K841969-LABELING

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    2.5MM & 4MM PROBE K841969-LABELING

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    ONE TOUCH ULTRA STRIP 100S

    FDA Adverse Event
    Malfunction ·LIFESCAN·Product code NBW·October 21, 2008

    MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCU-CHEK CONNECT DIABETES MANAGEMENT APP

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 30, 2014

    UNKNOWN ZIMMER KNEE IMPLANT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·November 14, 2012

    SIGMA 200 SR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code DXY·September 23, 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