BEUDAMED
    13 results · 18ms · Sources: EU EUDAMED, US FDA

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    AMYLAST-D TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CARDIOSOFT/CASE CARDIAC TESTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SAM JUNCTIONAL TOURNIQUET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLOEY CATHETER W TEMP

    FDA Adverse Event
    Injury ·DEGANIA SILICONE LTD·Product code DRF·October 17, 2017

    FOLEY CATHETER W TEMP

    FDA Adverse Event
    Malfunction ·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017

    FOLEY CATHETER W TEMP

    FDA Adverse Event
    Malfunction ·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017

    FOLEY CATHETER W TEMP

    FDA Adverse Event
    Malfunction ·DEGANIA SILICONE LTD.·Product code KOD·July 7, 2017

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD·Product code JGS·November 14, 2012

    EXCELLENCE+

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 10, 2015

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 10, 2010

    FOLEY CATHETER W TEMP

    FDA Adverse Event
    Malfunction ·MMJ SA DE CV (USD)·Product code DRF·November 9, 2018

    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