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

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure.

    FDA Enforcement
    Class II ·Terminated·Biocomposites, Ltd.·December 30, 2020

    2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·April 11, 2018

    2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO SYSTEM, OPTIONAL MODULE; 190618 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH; 190610 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; 190630 2008K2 MACHINE, SHORT CAB, OLC/DP, HP; 190628 2008K2 OLC ONLY WITH HEPARIN PUMP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.

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