7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
STRYKER TOTAL PERFORMANCE SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM
FDA 510(k)
FDA Class 2
·Microbiology
GEM Flow COUPLER Device and System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 5, 2013
EASYPUMP
FDA Adverse Event
Other
·I-FLOW CORP.·Product code MEB·December 8, 2010
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·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