7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SCHEIN AP-1 AIR POLISHING UNIT
FDA 510(k)
FDA Class 2
·Dental
CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE
FDA 510(k)
FDA Class 2
·Radiology
TrailBlazer Angled Support Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 10, 2012
*
FDA Adverse Event
Malfunction
·ANGIODYNAMICS INC.·Product code LJT·September 21, 2010
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