BEUDAMED
    8 results · 34ms · 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.

    RADIOGRAPHIC FILM MARKING SYSTEM

    FDA 510(k)
    FDA Class 1 ·Radiology

    PLIF CAGE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTMS INC.·Product code LZG·December 21, 2012

    XPRT

    FDA Adverse Event
    Malfunction ·GAYMAR INDUSTRIES, INC.·Product code IKY·November 24, 2010

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 3, 2014

    BD ULTRA-FINE¿ MINI PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·January 5, 2022

    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