BEUDAMED
    2 results · 12ms · Sources: EU EUDAMED, US FDA

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    2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395 2008KatHOME MACHINE, SHORT CAB, OLC/DP, HP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·May 6, 2015

    2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. - Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395 2008KatHOME MACHINE, SHORT CAB, OLC/DP, HP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDI·February 20, 2015