BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    Pointe Scientific Cocaine Metabolite Enzyme Immunoassay

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMPAX VOLUME VIEWING

    FDA 510(k)
    FDA Class 2 ·Radiology

    TUBE, GASTROINTESTINAL (AND ACCESS)

    FDA Adverse Event
    Malfunction ·C. R. BARD INC. (BASD)·Product code KNT·November 21, 2008

    TUBE, GASTROINTESTINAL (AND ACCESS)

    FDA Adverse Event
    Malfunction ·C. R. BARD INC. (BASD)·Product code KNT·October 24, 2008

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·October 22, 2014

    STERRAD 200, SINGLE DOOR

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·June 26, 2013

    EPIC II CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 1, 2011

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018