8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
GUIDER DASHER
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOVISION ENDOCULAR PROBE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·May 8, 2023
VICTORY
FDA Adverse Event
Malfunction
·BRIVANT, LTD.·Product code DQX·January 31, 2013
MULTI-LINK 8
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAF·January 3, 2011
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CUERNAVACA·Product code KDI·July 18, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021