7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
COLUMBIZ CNA AGAR W/5% SHEEP BLOOD
FDA 510(k)
FDA Class 1
·Microbiology
VP SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
D.N.E. External Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
INJECTION GOLD PROBE?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code KNS·June 5, 2014
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·October 4, 2010
PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·November 29, 2012
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021