BEUDAMED
    112 results · 23ms · Sources: EU EUDAMED, US FDA

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    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

    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 Recall
    Terminated ·On-X Life Technologies, Inc.·Product code PAW·December 13, 2016

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    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 Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code NBC·November 11, 2015

    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

    TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.

    FDA Enforcement
    Class I ·Terminated·Codman & Shurtleff, Inc.·January 29, 2014

    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