BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    THROMBIN TIME REAGENT

    FDA 510(k)
    FDA Class 2 ·Hematology

    OMS CRYO

    FDA 510(k)

    SPECIMEN TRAP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYMBIQ 3.13 DUAL CHA

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

    SOFTCLIX PLUS LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·October 23, 2007

    2124215-2010-21635

    FDA Adverse Event
    Malfunction ·GUIDANT PUERTO RICO BV·Product code LWS·November 9, 2010

    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