ValveDigest
Sign up

FDA & Regulatory

Recalls, PMA approvals, and adverse events for heart valve devices

Event Type

All EventsRecallPMA ApprovalAdverse Event

Company

All CompaniesABBOTT MEDICALAbbott MedicalCardinal HealthCardinal Health 200, LLCCorcym S.r.l.Cryolife IncEdwards Lifesciences, LLCLifeNetMedtronic, Inc.Occlutech Holding AGOn-X Life Technologies, Inc.W. L. Gore & Associates, Inc.
Clear filters
1 events
PMA ApprovalJul 28, 2026
FDA PMA: CARBOMEDICS PROSTHETIC HEART VALVE, CARBOMEDICS® SUPRA-ANNULAR PROSTHETIC HEART VALVE, OPTIFORM® PROSTHETIC MITRAL HEART

Company: Corcym S.r.l.

— Applicant: Corcym S.r.l.