BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    VARIAN C-SERIES CLINACS (CLINAC 2300C/D)

    FDA 510(k)
    FDA Class 2 ·Radiology

    VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ENDOGATOR ADVANTAGE IRRIGATION PUMP

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PWRD ECH FLEX 60MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·January 14, 2013

    IRIS RETRACTORS

    FDA Adverse Event
    Malfunction ·SYNERGETICS, INC.·Product code HNI·November 15, 2010

    ORTHO PROVUE

    FDA Adverse Event
    Malfunction ·MICROTYPING SYSTEMS·Product code KSZ·July 3, 2014

    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