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

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    (MSI) PATH-SAVER

    FDA 510(k)
    FDA Class 1 ·Pathology

    S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)

    FDA 510(k)
    FDA Unclassified ·Unknown

    BI-METRIC/X POR NC 11X135

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·March 17, 2021

    M2A-MAGNUM 42-50M TPR INSRT +3

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·March 24, 2021

    BIPOLAR LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·October 14, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·December 13, 2012

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 13, 2014

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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