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

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

    Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.

    FDA Enforcement
    Class II ·Terminated·On-X Life Technologies, Inc.·February 1, 2017

    Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. Catalog Number: CPBNPM SMN: 10445086

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics Inc·January 13, 2016

    Dimension Assays: Triglycerides (TGL)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016

    ADVIA CHEMISTRY ENZYMATIC CREATININE_2

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016

    Advia Chemistry Assay: Lactate

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016

    Dimension Assays: Uric Acid (URCA)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016

    Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016

    Dimension Vista Assays: Triglycerides (TRIG)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016

    Dimension Assays: ENZYMATIC CREATININE

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016

    Advia Chemistry Assay: LDL Cholesterol, Direct

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016

    Dimension Vista Assays: Uric Acid (URCA)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016

    Dimension Vista Assays: Enzymatic Creatine (ECRE)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016

    ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients over the preceding two-three weeks.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·June 17, 2020

    Dimension Vista Assays: Direct HDL Cholesterol (AHDL)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016

    Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016

    Dimension Assays: Direct HDL Cholesterol (AHDL)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016

    ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·June 17, 2020

    Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients over the preceding two-three weeks.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·June 17, 2020

    ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·August 26, 2015

    Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·June 17, 2020