BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    CHARACTERIZED FETAL BOVINE SERUM #A-1115

    FDA 510(k)
    FDA Class 1 ·Hematology

    ONDEMAND3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    StatStrip Xpress Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PINNACLE MTL INS NEUT40IDX60OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 12, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·October 11, 2010

    PINNACLE MTL INS NEUT36IDX50OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·December 12, 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