7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SCOVILLE-LEWIS ANEURYSM CLIPS
FDA 510(k)
FDA Class 2
·Neurology
Inion BioRestore
FDA 510(k)
FDA Class 2
·Orthopedic
CORONARY PRESSURE PERFUSION PUMP
FDA 510(k)
FDA Class 2
·Cardiovascular
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·January 21, 2014
MULTI-LINK 8
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAF·October 15, 2012
ECLIPSE FILTER SYSTEM -JUGULAR
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·August 4, 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