8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
NERVE STIMULATORS
FDA 510(k)
FDA Class 2
·Anesthesiology
LANEX Regular Screens
FDA UDI
CARESTREAM HEALTH, INC.·60889971771230·PR 18X24CM LANEX SCR REG C2
COPIOS BONE VOID FILLER SPONGE AND PASTE
FDA 510(k)
FDA Class 2
·Orthopedic
FMS VUE II Fluid Management and Tissue Debridement System
FDA 510(k)
FDA Class 2
·Orthopedic
SPRINT QUATTRO
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·April 24, 2014
SWAN-GANZ CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·October 3, 2012
CONTAK RENEWAL TR
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NKE·July 27, 2010
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