BEUDAMED
    7 results · 33ms · Sources: EU EUDAMED, US FDA

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    URIC ACID TEST

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MAMMOGRAPH III

    FDA 510(k)
    FDA Class 2 ·Radiology

    MCCOY CELLS

    FDA 510(k)
    FDA Class 1 ·Hematology

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS·Product code LYJ·June 10, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·October 11, 2010

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·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