2 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
×
On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions
FDA Enforcement
Class II
·Terminated·CryoLife, Inc.·July 19, 2017
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025