BEUDAMED
    12 results · 22ms · 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.
    Filters Regulation: Us FDA ×

    Fitbit Irregular Rhythm Notifications

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYSMEX UF-50

    FDA 510(k)
    FDA Class 2 ·Hematology

    PNEUPAC PARAPAC PLUS

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code BTL·April 17, 2024

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 15, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 9, 2013

    CARDIOSAVE HYBRID

    FDA Adverse Event
    Injury ·DATASCOPE CORP. - MAHWAH·Product code DSP·June 11, 2020

    DEEP BRAIN STIMULATION EXTENSION

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·February 4, 2016

    ACTIVA

    FDA Adverse Event
    Injury ·NEURO - VILLALBA·Product code MHY·February 4, 2016

    CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·January 16, 2013

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023