985 results · 14ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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 Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LDP·June 30, 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 Recall
Terminated ·Siemens Healthcare Diagnostics Inc·Product code NBC·November 11, 2015

PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma.

FDA Recall
Terminated ·Polymedco, Inc., Polymedco Cancer Diagnostic Products, Llc·Product code NBC·April 30, 2018

PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma.

FDA Recall
Terminated ·Polymedco, Inc., Polymedco Cancer Diagnostic Products, Llc·Product code JHX·April 30, 2018

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 Recall
Terminated ·Codman & Shurtleff, Inc.·Product code KGG·October 11, 2013

VIDAS NT-pro-BNP Product Usage: VIDAS NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA technique (EnzymeLinked Fluorescent Assay). The VIDAS NTproBNP (PBNP) test is used as an aid in the diagnosis of suspected congestive heart failure.

FDA Recall
Terminated ·Biomerieux France Chemin De L'Or Chemin De L'Orme Marcy L'Etoile France·Product code NBC·April 15, 2016

Dimension Assays: Uric Acid (URCA)

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code KNK·March 17, 2016

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

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LBS·March 17, 2016

SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073

FDA Recall
Terminated ·CSL Behring GmbH Emil-von-Behring-Str. 76 Marburg Germany·Product code CHN·June 5, 2017

Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code KNK·March 17, 2016

Advia Chemistry Assay: Lactate

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CFJ·March 17, 2016

Dimension Vista Assays: Direct HDL Cholesterol (AHDL)

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JHM·March 17, 2016

Dimension Assays: Triglycerides (TGL)

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDT·March 17, 2016

Dimension Vista Assays: Triglycerides (TRIG)

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDT·March 17, 2016

Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CHH·March 17, 2016

Dimension Vista Assays: Enzymatic Creatine (ECRE)

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JFY·March 17, 2016

ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDT·March 17, 2016

Dimension Vista Assays: Uric Acid (URCA)

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code KNK·March 17, 2016

ADVIA CHEMISTRY ENZYMATIC CREATININE_2

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JFY·March 17, 2016

Dimension Assays: ENZYMATIC CREATININE

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JFY·March 17, 2016