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

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    ANATECH HEMATOXYLIN-NORMAL STRENGTH

    FDA 510(k)
    FDA Class 1 ·Hematology

    NEOSHIELD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NOVOFLO CATHETER LT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 13, 2014

    1.9F ARGYLE SINGLE LUMEN PICC

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code LJS·October 8, 2010

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·December 13, 2012

    COBAS E 801 ANALYTICAL UNIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 27, 2025

    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