2 results
·
16ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
B105M Patient Monitor, REF 6160000-003
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 28, 2022
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