BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    MASCOT O.R. TOWEL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CHEMONUCLEOLYSIS NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VIROGEN RUBELLA MICROTITER TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    GEMSTAR PAIN MGE SNG

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 25, 2014

    ENDOTAK SQ

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code DTB·November 9, 2010

    TILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC·Product code CBK·December 27, 2012

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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

    PM 1260 ASSURITY + 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