BEUDAMED
    11 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.

    CADWELL 8400

    FDA 510(k)
    FDA Class 2 ·Neurology

    Cooler Heads

    FDA UDI
    PATHWAY, LLC·00851682007562·AMMA Portable Scalp Cooling System

    AMMA

    FDA UDI
    Cooler Heads Care, Inc.·00850051245000·

    MOD. DM-356 IPS INTERFACE MODULE

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

    L-15 MEDIUM (MODIFIED)

    FDA 510(k)
    FDA Class 1 ·Hematology

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·January 24, 2019

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 23, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 13, 2012

    PENUMBRA ASPIRATION PUMP

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code BTA·March 15, 2010

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·December 28, 2018

    EV3 Pipeline Flex Embolization Device with Flex Shield Technology

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021