Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valves and Edwards SAPIEN 3 Ultra Transcatheter Heart Valves

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Certitude Delivery System

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·INSPIRIS RESILIA Aortic Valve, Model 11500A

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Magna Ease Aortic Heart Valve

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRODISC-L TOTAL DISC REPLACEMENT

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PERIMOUNT, RSR, THEON, RSR PERICARDIAL AORTIC BIOPROSTHESES & VARIOUS FAMILIES OF MAGNA, THEON, PLUS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Inspiris Resilia Aortic Valve, and Edwards Pericardial Mitral Bioprosthesis

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MANTA™ Vascular Closure Device

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Sapien XT Transcatheter Heart Valve

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 XT TRANSCATHETER HEART VALVE AND ACCESSORIES

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·ProDisc-L Total Disc Replacement

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Sapien 3 Transcatheter Heart Valve