BEUDAMED
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    DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    REDY SORBENT MACHINE #1

    FDA Adverse Event
    Injury ·ORGANON TEKNIKA·Product code FKT·February 2, 1993

    NXSTAGE

    FDA Adverse Event
    Death ·NXSTAGE MEDICAL INC., 43 SOUTH UNION ST., LAWRENCE·Product code KDI·August 12, 2023

    DIALOG+®

    FDA Adverse Event
    Malfunction ·B. BRAUN AVITUM AG·Product code KDI·April 11, 2023

    DIALOG+®

    FDA Adverse Event
    Malfunction ·B. BRAUN AVITUM AG·Product code KDI·April 11, 2023

    DIALOG+®

    FDA Adverse Event
    Malfunction ·B. BRAUN AVITUM AG·Product code KDI·April 12, 2023

    DIALOG+®

    FDA Adverse Event
    Malfunction ·B. BRAUN AVITUM AG·Product code KDI·April 12, 2023

    DIALOG+®

    FDA Adverse Event
    Malfunction ·B. BRAUN AVITUM AG·Product code KDI·April 12, 2023

    DIALOG+®

    FDA Adverse Event
    Malfunction ·B. BRAUN AVITUM AG·Product code KDI·April 11, 2023

    DIALOG+®

    FDA Adverse Event
    Malfunction ·B. BRAUN AVITUM AG·Product code KDI·April 11, 2023

    DIALOG+

    FDA Adverse Event
    Death ·B. BRAUN AVITUM AG - MELSUNGEN·Product code KDI·June 9, 2021

    DIALOG+®

    FDA Adverse Event
    Malfunction ·B. BRAUN AVITUM AG·Product code KDI·April 12, 2023

    DIALOG+®

    FDA Adverse Event
    Malfunction ·B. BRAUN AVITUM AG·Product code KDI·April 12, 2023

    DIALOG+®

    FDA Adverse Event
    Malfunction ·B. BRAUN AVITUM AG·Product code KDI·April 12, 2023

    DIALOG+®

    FDA Adverse Event
    Malfunction ·B. BRAUN AVITUM AG·Product code KDI·April 12, 2023

    DIALOG A + 1 BLOOD PUMP 120V

    FDA Adverse Event
    Death ·B. BRAUN AVITUM AG - MELSUNGEN·Product code FKJ·December 14, 2016

    COMPANION 1000

    FDA Adverse Event
    Injury ·CAIRE, INC.·Product code BYJ·September 20, 2011

    TABLO HEMODIALYSIS SYSTEM

    FDA Adverse Event
    Death ·OUTSET MEDICAL, INC.·Product code KDI·August 18, 2020

    DIALOG A +INCL. BIC

    FDA Adverse Event
    Malfunction ·B.BRAUN AVITUM AG·Product code FKJ·May 16, 2017

    TABLO HEMODIALYSIS SYSTEM

    FDA Adverse Event
    Death ·OUTSET MEDICAL, INC.·Product code KDI·August 4, 2020