BEUDAMED
    4 results · 11ms · Sources: EU EUDAMED, US FDA

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    ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-26, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-001.

    FDA Recall
    Terminated ·Product code FGE·January 18, 2008

    ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-16, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-000.

    FDA Recall
    Terminated ·Product code FGE·January 18, 2008

    ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-36, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-002. ev3 IntraStent DoubleStrut Peripheral Stent, Model Number: S11-36, Catalog Number: 90-1075-002 (not approved within the USA).

    FDA Recall
    Terminated ·Product code FGE·January 18, 2008

    UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·October 1, 2014