2,327 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesi
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic Bioprosthesis with ThermaFix tis
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
·PERIMOUNT Bioprosthesis, PERIMOUNT Magna Aortic Bioprosthesis, PERIMOUNT Magna Ease Bioprosthesis, PERIMOUNT Plus Biopro
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Edwards SAPIEN 3, Ultra 3 Transcatheter Heart Valve
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Edwards SAPIEN 3 Transcatheter Heart Valve and SAPIEN 3 Ultra Transcatheter Heart Valve
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·Mentor MemoryShape Breast Implants
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·EDWARDS INTUITY Elite Valve System
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EDWARDS SAPIEN TRANSCATHETER HEART VALVE
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·M6-C Artificial Cervical Disc
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Edwards INTUITY Elite Valve, Edwards INTUITY Elite Valve Delivery System
Artificial Heart
FDA Pre-Market Approval
FDA Class 3
·SynCardia temporary Toatl Artificial Heart (TAH-t) System - Companion 2 Driver System
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·M6-C Artificial Cervical Disc
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS
Prosthesis, Breast, Inflatable, Internal, Saline
FDA Pre-Market Approval
FDA Class 3
·MENTOR SPECTRUM SALINE-FILLED MAMMARY PROSTHESES
Mitral Valve Repair Devices
FDA Pre-Market Approval
FDA Class 3
·PASCAL Precision Transcatheter Valve Repair System