8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DEN-MAT DENTIN LINK
FDA 510(k)
FDA Class 2
·Dental
Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EMPOWERMR INJECTOR SYSTEM, MODEL 9730
FDA 510(k)
FDA Class 2
·Cardiovascular
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 8, 2010
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·December 10, 2012
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
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020