Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·SVS APEX PLUS EXCIMER LASER WORKSTATION AND EMPHASIS DISC

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ITREL 3 INS/SYNERGY FAMILY INS/EXTENSION KIT, RESTORE/POCKET ADAPTORS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ITREL 3 INS/SYNERGY FAMILY INS/EXTENSION KIT, RESTORE/POCKET ADAPTORS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC AND MITRAL VALVES

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADAR VISION EXCIMER LASER SYSTEM (HYPEROPIA)

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSITED IN SITU KERATOMILEUSIS (LASIK)

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·TECHNOLAS 217A EXCIMER LASER SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostat Agent - Microfibrillar Form

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Helistat Absorbable Collagen Hemostatic Sponge

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·Integra Dermal Regeneration Template

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COGNIS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RESTYLANE, RESTYLANE-L, RESTYLANE LYFT, RESTYLANE SILK, PERLANE

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADARVISION 4000 EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODEL C STAR

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX STAR EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·NIDEK EC-5000 EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX STAR EXCIMER LASER SYSTEM