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

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    1.1 SCREWDRIVERS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    eUnity

    FDA 510(k)
    FDA Class 2 ·Radiology

    REIGNING DENTURE

    FDA 510(k)
    FDA Class 2 ·Dental

    PLUM XLM W/DATAPORT

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 18, 2014

    TERUMO TCM II COOLING AND HEATING SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·December 12, 2012

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 8, 2010

    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