BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    COULTER MEAN PLATELET VOLUME CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Hematology

    Retraxil

    FDA 510(k)
    FDA Unclassified ·Unknown

    DONALDSON VENT TUBE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·June 2, 2014

    TOTAL ASR ACET IMP SIZE 62

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·November 23, 2012

    DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC. (CRM-KISTA)·Product code NVY·June 15, 2015

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF 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