BEUDAMED
    9 results · 19ms · 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.

    IGF-I BY EXTRACTION; INSULIN-LIKE GROWTH FACTOR I

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SARNS MEMBRANE OXYGENATOR W/INTEGRAL CARDIO RESERV

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PATIENT EXAMINATION GLOVES (LATEX)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    FDA Adverse Event
    Malfunction ·EUROSETS S.R.L.·Product code DTZ·December 11, 2023

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·May 20, 2014

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·Product code KDJ·November 11, 2010

    MAYFIELD MODIFIED SKULL CLAMP

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code HBL·December 28, 2012

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    FDA Adverse Event
    Malfunction ·EUROSETS S.R.L.·Product code DTZ·August 21, 2023

    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