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

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    ALTAIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    E-SCAN MRI SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEPAIRX VENTILATING AIR PURIFIER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LC4200 PCA PLUS AUST

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·March 8, 2012

    LC4200 PCA AUST

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code MEA·October 20, 2010

    PCA PUMP (AUZ)

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code MEA·March 13, 2012

    LC4200 PCA PLUS AUST

    FDA Adverse Event
    Injury ·HOSPIRA COSTA RICA LTD.·Product code MEA·March 1, 2012

    PCA PUMP (AUZ)

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code MEA·June 2, 2010

    TRI TS BASEPLATE SIZE 4

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·January 7, 2013

    KARL STORZ

    FDA Adverse Event
    Other ·KARL STORZ GMBH & CO. KG·Product code FGM·November 22, 2010

    PULSE GEN MODEL 102

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·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