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

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    HEART PACK II

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MODIFIED PYROGEN TESTING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESPIRONICS' DIGITAL MANOMETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ENDOSTAT ELECTROSURGICAL UNIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNS·December 6, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 5, 2014

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 20, 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