3,221 results · 105ms · Sources: EU EUDAMED, US FDA

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS COMMANDER DELIVERY SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

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

Mitral Valve Repair Devices

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

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·INSPIRIS™ RESILIA™ Aortic Valve, KONECT RESILIA Aortic Valve Conduit (AVC)

Monitor, Lung Water Measurement

FDA Pre-Market Approval
FDA Class 3 ·MODEL 9310 LUNG WATER COMPUTER

Replacement Heart-Valve

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

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS INTUITY Elite Valve System

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process

Replacement Heart-Valve

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

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 ·S.A.V. BIOPROSTHESIS MODEL 2650 (AORTIC)

Aortic Valve, Prosthesis, Percutaneously Delivered

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

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)

Aortic Valve, Prosthesis, Percutaneously Delivered

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

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PORCINE AORTIC BIOPROTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROTHESIS

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 CRIMPER

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·NEW BRANSON ULTRASONIC WELDER GENII

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES MODELS 2700/2700TFX/2800/2800TFX/3000/3000TFX/3300TFX/6900P/PTFX

Replacement Heart-Valve

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