BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    FUZZY TRAY

    FDA 510(k)
    FDA Class 1 ·Dental

    PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA

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

    VTI SUCTION IRRIGATION SYSTEM

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

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·May 30, 2014

    PFM TITA JET LIGHT II

    FDA Adverse Event
    Malfunction ·PFM MEDICAL, INC·Product code LJS·September 23, 2012

    GRASEBY MS 26 SYRINGE DRIVER

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code FRN·September 16, 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