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

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    U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LP4 VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 10, 2014

    VITALITY

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 11, 2010

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·December 10, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015