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

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    2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·March 7, 2018

    Fresenius 2008T Hemodialysis Machine Part Number 190573, 2008T Hemodialysis System, OLCIDIASAFE PLUS Part Number 190713, 2008T Hemodialysis System with CDX Part Number 190766, 2008T Hemodialysis System with biBag The Fresenius 2008T is indicated for acute and chronic dialysis therapy.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·January 19, 2011

    2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.

    FDA Recall
    Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code KDI·July 13, 2018

    2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·September 26, 2018

    2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG; 190858 2008T HEMODIALYSIS SYSTEM WITHOUT CDX 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

    Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. Used in conjunction with the Fresenius 2008T Hemodialysis Machines as follows: Model: 190895 2008T GEN 2 BIBAG w/o CDX 190713 2008T Hemodialysis SYS with CDX 190858 2008T Hemodialysis System w/o CDX 190766 2008T Hemodialysis System w/o CDX

    FDA Recall
    Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code KOC·May 24, 2016

    2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG; 190858 2008T HEMODIALYSIS SYSTEM WITHOUT CDX The Fresenius 2008K is indicated for acute and chronic dialysis therapy.

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

    Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. Used in conjunction with the Fresenius 2008T Hemodialysis Machines as follows: Model: 190895 2008T GEN 2 BIBAG w/o CDX 190713 2008T Hemodialysis SYS with CDX 190858 2008T Hemodialysis System w/o CDX 190766 2008T Hemodialysis System w/o CDX

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·June 29, 2016