BEUDAMED
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    Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive

    FDA Enforcement
    Class II ·Completed·Withings Sas·August 22, 2018

    INTEGO PET INFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·BAYER MEDICAL CARE, INC.·Product code LLY·August 3, 2016

    INTEGO PET INFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·BAYER MEDICAL CARE, INC.·Product code FRN·August 1, 2016

    INTEGO PET INFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·BAYER MEDICAL CARE, INC.·Product code LLY·August 3, 2016

    INTEGO PET INFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·BAYER MEDICAL CARE, INC.·Product code LLY·August 1, 2016

    POWERLED

    FDA Adverse Event
    Injury ·MAQUET SAS·Product code FSY·April 30, 2018

    LUCEA 100

    FDA Adverse Event
    Malfunction ·MAQUET SAS·Product code FSY·September 7, 2018

    MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016

    POWERLED

    FDA Adverse Event
    Malfunction ·MAQUET SAS·Product code FSY·October 31, 2017

    VOLISTA STANDOP

    FDA Adverse Event
    Malfunction ·MAQUET SAS·Product code FSY·June 11, 2018

    VENATECH

    FDA Adverse Event
    Injury ·B.BRAUN MEDICAL SAS - OWNER·Product code DTK·October 19, 2016

    VOLISTA

    FDA Adverse Event
    Malfunction ·MAQUET SAS·Product code FSY·October 12, 2018

    VOLISTA

    FDA Adverse Event
    Malfunction ·MAQUET SAS·Product code FSY·October 12, 2018

    INTRATHECAL CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·January 12, 2016

    IMPLANTABLE INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·January 12, 2016

    Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive

    FDA Recall
    Completed ·Withings Sas 2 rue Maurice Hartmann Issy les Moulineaux France·Product code DXN·June 11, 2018

    VOLISTA 600 SF STANDOP

    FDA Adverse Event
    Malfunction ·MAQUET SAS·Product code FSY·January 26, 2018

    VOLISTA

    FDA Adverse Event
    Malfunction ·MAQUET SAS·Product code FSY·August 3, 2018

    ONDASPACE

    FDA Adverse Event
    Malfunction ·MAQUET SAS·Product code FSY·July 31, 2018

    VOLISTA

    FDA Adverse Event
    Malfunction ·MAQUET SAS·Product code FSY·August 16, 2018