Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Qualcrimp crimping accessory (Packaged with the Commander Delivery System)

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Intuity Elite Valve System

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC AND MITRAL BIOPROSTHESES DEVICE FAMILIES

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Commander Delivery System

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·STARR-EDWARDS SILASTIC BALL PROSTHESIS,MODELS 1260 & 6120

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Commander Delivery System

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·PASCAL Precision Transcatheter Valve Repair System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRODISC L TOTAL DISC REPLACEMENT

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

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

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·GEM 21S (GROWTH-FACTOR ENHANCED MATRIX)

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·QUALCRIMP CRIMPING ACCESSORY (LAMINATED)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·prodisc L

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Prometra Programmable Infusion Pump System