Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Commander Delivery System

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·SALINE-FILLED & SPECTRUM BREAST IMPLANTS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Commander Delivery System

Intraocular Lens

FDA Pre-Market Approval

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

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon PanOptix Trifocal UV Absorbing Hydrophobic Intraocular Lens (IOL), Clareon PanOptix Toric Trifocal Hydrophobic I

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS INTUITY ELITE Valve/Delivery System

Intraocular Lens

FDA Pre-Market Approval

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

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, PERIMOUNT THEON PERICARDIAL AORTIC BIOPROSTHESIS

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

FDA Pre-Market Approval

FDA Class 3 ·MEMORYSHAPE BREAST IMPLANTS, CONTOUR PROFILE GEL IMPLANTS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·NOVAFLEX + DELIVERY SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625 AND 6625 AND VALVED CONDUIT MODEL 4300

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS 3000, 3000TFX(AORTIC), 6900P & 6900PTFX(MITRAL)

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

FDA Pre-Market Approval

FDA Class 3 ·MENTOR MemoryShape Breast Implants

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS VALVED CONDUIT, MODEL 4300

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

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

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MANTA Vascular Closure Device