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

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    FIAX LYME M TEST KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Swish™ GPS® Abutment

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307116073·

    FIREBIRD SFS

    FDA UDI
    Orthofix US LLC·18257200116836·FIXED CROSS CONNECTOR CADDY, FIREBIRD

    TI-CORE (DENTAL COMPOSITE)

    FDA 510(k)
    FDA Class 2 ·Dental

    CARDIOVUE CFS-100

    FDA 510(k)
    FDA Class 2 ·Radiology

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING·Product code FJI·May 28, 2014

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 22, 2010

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·January 9, 2013

    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