Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·MEL 80 Excimer Laser

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Sphere, Biofinity Toric, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Contact

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·MEL 80 EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·MEL 80 Excimer Laser System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·MEL 80 Excimer Laser System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·MEL 80 EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·MEL 90 EXCIMER LASER SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SILICONE POSTERIOR CHAMBER INTRACULAR LENSES IOL MODEL 127(920)

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·MEDITEC MEL 80 EXCIMER LASER SYSTEM

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System (OCS™) Liver

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System (OCS™) Lung System

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System (OCS) Heart System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) MDL 6966, 6936, 6963 TRANSVENE(R) AND MODEL 6939 AND 6999 SUBCUTANEOUS PATCH LEADS.

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADET V-105 C AND D AND V-115 C AND D PULSE GENERATORS & SOFTWARE VERSION 4.1 FOR THE PROGRAMMER MDL PR-1500

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NovaSure Impedance Controlled Endometrial Ablation System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Mara Vapor System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDENCE CONTROLLED ABLATION SYSTEM