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

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    ALPHA-DENT PIT AND FISSURE SEALANT

    FDA 510(k)
    FDA Class 2 ·Dental

    E-Z SET/MINICATH INFUSION SETS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MICROZYME THC ENZYME IMMUNOASSAY TEST KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LIGACLIP MCA

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC·Product code FZP·January 16, 2013

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·December 14, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 10, 2014

    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