3,221 results · 103ms · Sources: EU EUDAMED, US FDA

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODEL 2700, 2700TFX, 2800TFX, 3000, 3000TFX, 6900, 6900P PERIMOUN

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Carpentier-Edwards PERIMOUNT Plus Pericardial Mitral Bioprosthesis/Theon Pericardial Mitral Bioprosthesis with ThermaFix

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·INTUITY Delivery System - Accessories

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·PASCAL Precision Transcatheter Valve Repair System

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS

Aortic Valve, Prosthesis, Percutaneously Delivered

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

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards Certitude Introducer Sheath Set, Models 9600IS18, 9600IS21

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS, MODEL 2650

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·TRANSCATHER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES

Aortic Valve, Prosthesis, Percutaneously Delivered

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

Aortic Valve, Prosthesis, Percutaneously Delivered

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

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·STARR EDWARDS SILASTIC BALL VALVE

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards SAPIEN 3™ Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CAPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CAPENTIER-EDWARDS PERIMOUNT THEON, THEON PSR, MAGNA, MAGNA EASE, PERICARDIAL AORTIC BIOPROSTHESIS

Aortic Valve, Prosthesis, Percutaneously Delivered

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

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards Crimper model 9600CR

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS

Aortic Valve, Prosthesis, Percutaneously Delivered

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