14 results
·
49ms
·
Sources: EU EUDAMED, US FDA
VITROS CHEMISTRY PRODUCTS VANC REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LEH·March 11, 2022
VITROS CHEMISTRY PRODUCTS VANC REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LEH·June 22, 2021
VITROS CHEMISTRY PRODUCTS VANC REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LEH·June 22, 2021
VITROS XT 7600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·January 22, 2025
FREESTYLE NAVIGATOR
FDA Adverse Event
Injury
·Product code LFR·March 15, 2010
FREESTYLE LITE
FDA Adverse Event
Malfunction
·Product code NBW·April 2, 2010
FREESTYLE LITE
FDA Adverse Event
Malfunction
·Product code NBW·April 18, 2010
FREESTYLE
FDA Adverse Event
Malfunction
·Product code NBW·February 12, 2010
VITROS CHEMISTRY PRODUCTS VANC REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LEH·March 4, 2008
INFUSOMAT®
FDA Adverse Event
Malfunction
·B.BRAUN MELSUNGEN AG·Product code FRN·January 4, 2024
Cook Urological, Inc. Koyle Diaper Stent 6.0 Fr, Sterile, GPN G17667, REF KDSCF-060050.
FDA Recall
Terminated
·Vance Products Inc. dba Cook Urological Inc. & Cook OB/GYN·Product code KOD·December 13, 2010
The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2 Systems for the automated identification of most clinically significant anaerobic organisms and Corynebatcerium species. The VITEK¿ 2 ANC identification card is a single-use disposable. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
FDA Enforcement
Class II
·Terminated·BioMerieux SA·June 20, 2018
The IS Can Disposable CO2 absorber x 6 --- Carbon Dioxide absorbent for use on GE rebreathing systems --- Manufactured in the United Kingdom for: Intersurgical Incorporated --- 417 Electronics Parkway, Liverpool, NY 13088. Intended use: GE Healthcare anesthetic machines: S5 Aespire, S5 Avance, Aisys. The Intersurgical IS Can is for use with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane.
FDA Recall
Terminated
·Intersurgical Inc·Product code BSF·February 9, 2011
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