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    Gambro Renal Products, Inc.

    Manufacturer
    🇺🇸 United States

    POLYFLUX REVACLEAR

    FDA UDI
    GAMBRO RENAL PRODUCTS, INC.·07332414101695·Revaclear-Revaclear Max are indicated for the t...

    REVACLEAR

    FDA UDI
    GAMBRO RENAL PRODUCTS, INC.·07332414123055·Revaclear 300 and 400 dialyzers are indicated f...

    POLYFLUX REVACLEAR MAX

    FDA UDI
    GAMBRO RENAL PRODUCTS, INC.·07332414101701·Revaclear-Revaclear Max are indicated for the t...

    REVACLEAR

    FDA UDI
    GAMBRO RENAL PRODUCTS, INC.·07332414124076·Revaclear 400 dialyzer is indicated for treatme...

    Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.

    FDA Enforcement
    Class II ·Terminated·Gambro Renal Products, Incorporated·May 28, 2014

    Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.

    FDA Recall
    Terminated ·Gambro Renal Products, Incorporated·Product code KDI·April 16, 2014

    Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.

    FDA Enforcement
    Class II ·Terminated·Gambro Renal Products, Incorporated·May 28, 2014

    Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.

    FDA Recall
    Terminated ·Gambro Renal Products, Incorporated·Product code KDI·April 16, 2014

    PRISMA

    FDA Adverse Event
    Malfunction ·GAMBRO RENAL PRODUCTS, INC.·Product code KDI·November 14, 2016

    CVVH, BLOOD PUMP

    FDA Adverse Event
    Malfunction ·GAMBRO RENAL PRODUCTS, INC.·Product code KDI·January 30, 2012

    PRISMAFLEX

    FDA Adverse Event
    Malfunction ·GAMBRO RENAL PRODUCTS, INC.·Product code MQS·January 3, 2009

    *

    FDA Adverse Event
    Death ·GAMBRO RENAL PRODUCTS, INC.·Product code FII·February 25, 2004

    POLYFLUX REVACLEAR DIALYZER

    FDA Adverse Event
    Injury ·GAMBRO RENAL PRODUCTS INC.·Product code KDI·March 19, 2010

    PRISMAFLEX

    FDA Adverse Event
    Malfunction ·GAMBRO RENAL PRODUCTS, INC·Product code MQS·January 18, 2010

    PRISMAFLEX

    FDA Adverse Event
    Malfunction ·GAMBRO RENAL PRODUCTS, INC·Product code MQS·January 24, 2010

    PRISMAFLEX

    FDA Adverse Event
    Malfunction ·GAMBRO RENAL PRODUCTS, INC.·Product code MQS·January 18, 2010

    PRISMAFLEX

    FDA Adverse Event
    Malfunction ·GAMBRO RENAL PRODUCTS, INC·Product code MQS·January 24, 2010

    POLYFLUX REVACLEAR DIALYZER

    FDA Adverse Event
    Injury ·GAMBRO RENAL PRODUCTS INC.·Product code KDI·February 24, 2010

    PRISMAFLEX

    FDA Adverse Event
    Malfunction ·GAMBRO RENAL PRODUCTS, INC.·Product code MQS·January 16, 2010