Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·AQUASEPT II

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (ETAFILCON A) BRAND CONTACT LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODIFIED J & C LLOP POST. CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ULTRAVIOLET ABSORBING POSTERIOR CHAMBER IOL LENSES

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WAVELIGHT EX500 EXCIMER LASER SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CUSTOMEYES 70L & 79L (LIDOFILCON A&B)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SILICONE UV ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SYNVISC HYLAN G-F 20

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT/LT- CAGE LUMBAR TAPERED FUSION DEVICE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VIFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·OXFORD PARTIAL KNEE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE(R) BONE GRAFT

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·Healon Ultimate Dual Pack, HEALON, HEALON GV, HEALON5, and Healon Duet Dual Pack products

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·SILIKON 1000 OCULAR ENDOTAMPONADE