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

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    Filters Classification: Class Iii × Status: Terminated × Clear all

    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.5GAL Catalog Number: OFD3201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    FDA Enforcement
    Class III ·Terminated·Fresenius Medical Care Holdings, Inc.·January 23, 2013

    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2325-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    FDA Enforcement
    Class III ·Terminated·Fresenius Medical Care Holdings, Inc.·January 23, 2013

    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2223-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    FDA Enforcement
    Class III ·Terminated·Fresenius Medical Care Holdings, Inc.·January 23, 2013

    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD1201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    FDA Enforcement
    Class III ·Terminated·Fresenius Medical Care Holdings, Inc.·January 23, 2013

    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL Catalog Number: OFD2225-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    FDA Enforcement
    Class III ·Terminated·Fresenius Medical Care Holdings, Inc.·January 23, 2013

    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL Catalog Number: OFD2231-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    FDA Enforcement
    Class III ·Terminated·Fresenius Medical Care Holdings, Inc.·January 23, 2013

    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    FDA Enforcement
    Class III ·Terminated·Fresenius Medical Care Holdings, Inc.·January 23, 2013

    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD2201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    FDA Enforcement
    Class III ·Terminated·Fresenius Medical Care Holdings, Inc.·January 23, 2013

    Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    FDA Enforcement
    Class III ·Terminated·Fresenius Medical Care Holdings, Inc.·January 23, 2013

    Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis

    FDA Enforcement
    Class III ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·December 5, 2018

    Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis

    FDA Enforcement
    Class III ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·December 5, 2018

    Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis

    FDA Enforcement
    Class III ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·December 5, 2018

    ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human whole blood.

    FDA Enforcement
    Class III ·Terminated·Abbott Laboratories·May 22, 2019

    ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.

    FDA Enforcement
    Class III ·Terminated·Abbott Laboratories·May 22, 2019

    ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.

    FDA Enforcement
    Class III ·Terminated·Abbott Laboratories·May 22, 2019

    ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood.

    FDA Enforcement
    Class III ·Terminated·Abbott Laboratories·May 22, 2019

    Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.

    FDA Enforcement
    Class III ·Terminated·Smiths Medical ASD Inc.·September 26, 2018

    Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

    FDA Enforcement
    Class III ·Terminated·Abbott Laboratories·May 22, 2019

    Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

    FDA Enforcement
    Class III ·Terminated·Abbott Laboratories·May 22, 2019

    ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma.

    FDA Enforcement
    Class III ·Terminated·Abbott Laboratories·May 22, 2019