10,000 results · 54ms · Sources: EU EUDAMED, US FDA

Aortic Valve, Prosthesis, Percutaneously Delivered

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

Replacement Heart-Valve

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

Replacement Heart-Valve

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

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval
FDA Class 3 ·AUGMENT Bone Graft and AUGMENT Injectable

Aortic Valve, Prosthesis, Percutaneously Delivered

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

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·PROMETRA PATIENT THERAPY CONTROLLER

Artificial Heart

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

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval
Edwards Commander Delivery System

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve

Heart-Valve, Non-Allograft Tissue

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

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MemoryShape Breast Implants

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval
FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Replacement Heart-Valve

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

Replacement Heart-Valve

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

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lenses

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon PanOptix Hydrophobic Acrylic IOL works

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS SUPRAANULAR BIOPROSTHESIS MODEL 2650

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

FDA Pre-Market Approval
FDA Class 2 ·HEMASHIELD(R) WOVEN DOUBLE VELOUR GRAFT

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·ISPAN SULFUR HEXAFLUORIDE SF6 GAS