Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SYNCARDIA CAMPANION 2 DRIVER SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM RETROFLEX BALLOON CATHETER EDWARDS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·prodisc C Total Disc Replacement

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·PERIMOUNT, PERIMOUNT MAGNA AND PERIMOUNT PLUS PERCARDIAL BIOPROSTHESES

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN 3 Transcatheter Heart Valve and Accessories

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon PanOptix Pro Trifocal Intraocular Lens (IOL), Clareon PanOptix Pro Trifocal Toric IOLs, Clareon PanOptix Pro Tr

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Certitude Introducer Sheath Set

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MENTOR SALINE -FILLED & SPECTRUM BREAST IMPLANTS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Commander Delivery System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 (XT) Transcatheter Heart Valves

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS SUPRANNULAR (S.A.V.) BIOPROSTHESIS, MODEL 2650,6650

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700TFX, 2800TFX, 3000TFX, AND 6900PTX

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve Systems