10,000 results · 61ms · Sources: EU EUDAMED, US FDA

Embolization Agent, Vascular

FDA Pre-Market Approval
FDA Class 3 ·LAVA® Liquid Embolic System (LAVA LES)

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval
FDA Class 3 ·FLUORO-CEP (R) PROGESTERONE

Reherniation Reduction Device

FDA Pre-Market Approval
FDA Class 3 ·Barricaid® Annular Closure Device

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Sapien XT Transcatheter Heart Valve

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Sapien 3 Transcatheter Heart Valve

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·PIPELINE EMBOLIZATION DEVICE

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APILGRAF

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards Sapien 3 Ultra Delivery System and Edwards Commander Delivery System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards eSheath Introducer Set

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards SAPIEN XT Transcatheter Heart Valve

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT AORTIC & MITRAL BIOPROSTHESIS FAMILIES

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES

Acute Coronary Syndrome Event Detector

FDA Pre-Market Approval
FDA Class 3 ·AngelMed Guardian System

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF (GRAFTSKIN)

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE (THV)

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·BRACAnalysis CDx®