8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
IMMUNOGLOBULIN G NEPHEL. ASSAY
FDA 510(k)
FDA Class 2
·Immunology
VEINOPLUS NEUROMUSCULAR STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern
FDA 510(k)
FDA Class 2
·Immunology
CMV IGG ELECSYS E2G
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFZ·May 23, 2024
KANGAROO EPUMP SAFETY SCREW SPIKE WITH FLUSH BAG
FDA Adverse Event
Malfunction
·COVIDIEN LLC·Product code LZH·April 22, 2014
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code MNT·October 4, 2012
ACRYSOF IQ TORIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD/HUNTINGTON·Product code HQL·July 22, 2010
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021