BEUDAMED
    85 results · 21ms · Sources: EU EUDAMED, US FDA

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    Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.

    FDA Recall
    Terminated ·Oxford Immunotec·Product code OJN·July 16, 2020

    Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.

    FDA Recall
    Terminated ·Oxford Immunotec·Product code OJN·July 16, 2020

    Custom Kit, REF: K05-00843, Revision L, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DQO·April 15, 2008

    Custom Kit, Custom Angiographic Kit, REF: K05-YS1032, Revision A, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DQO·April 15, 2008

    Custom Kit, Custom Angiographic Kit, REF: K05-YS1025, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DQO·April 15, 2008

    biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers)

    FDA Recall
    Terminated ·Medtronic Emergency Response Systems, Inc.·Product code MKT·June 13, 2007

    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

    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