2,333 results · 20ms · Sources: EU EUDAMED, US FDA

Replacement Heart-Valve

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

Aortic Valve, Prosthesis, Percutaneously Delivered

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

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESES WITH THERMAFIX TISSUE PROCESS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·RESILIA Aortic Valve

Glenoid Fossa Prosthesis

FDA Pre-Market Approval
FDA Class 3 ·TMJ FOSSA EMINENCE/CONDYLAR PROSTHESIS SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Mitral Bioprosthesis

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Crimper

Aortic Valve, Prosthesis, Percutaneously Delivered

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

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 ·EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PLUS MITRAL PERICARDIAL BIOPROSTHESIS MODEL 6900PTFX

Aortic Valve, Prosthesis, Percutaneously Delivered

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

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART, MODEL 9000TFX

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·MENTOR SALINE FILLED BREAST IMPLANTS AND SPECTRUM BREAST IMPLANTS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Intuity Elite Delivery System

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis/Inspiris Resilia Aortic Valve