BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    TERUMO SENSIBEAD EIA FSH KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TOOTH CONDITIONER

    FDA 510(k)
    FDA Class 2 ·Dental

    MYOPULSE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ENDURANT II

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·June 10, 2014

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·October 11, 2010

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·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