2,350 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Theon RSR Pericardial
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHETIC VALVES
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·PROMETRA PROGRAMMABLE IMPLANTABLE PUMP
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC AND MITRAL VALVES
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwards
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve and Accessories
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Edwards Commander Delivery System
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·PRODISC-C TOTAL DISC REPLACEMENT
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, Edwards SAPIEN 3 Ultra RES
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·SYNTHES PRODISC-C TOTAL DISC REPLACEMENT
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES
Artificial Heart
FDA Pre-Market Approval
FDA Class 3
·SynCardia temporary Total Artificial Heart (TAH-t) System
Artificial Heart
FDA Pre-Market Approval
FDA Class 3
·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·ASCENDRA BALLOON AORTIC VALVULOPLASTY CATHETER
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·PRODISC C TOTAL DISC REPLACEMENT
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 3
·AccelStimTM Bone Growth Stimulator
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Edwards Pericardial Aortic Bioprothesis, Inspiris Resilia Aortic Valve