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

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV ABSORBING POSTERIOR CHAMBER IOL

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRODISC -L TOTAL DISC REPLACEMENT DEVICE

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

FDA Pre-Market Approval

FDA Class 3 ·R3 delta Ceramic Acetabular System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR EXCIMER LASER SYSTEM

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·OSTEOSTIM(TM) IMPLANTABLE BONE GROWTH STIMULATOR

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PERMAFLEX NATURALS (SURFILCON A) AND PERMAFLEX UV NATURALS (VASURFILCON A) HYDROPHILIC CONTACT LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STORZ POSTERIOR CHAMBER INTRAOCULAR LENSES

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·Biomet OrthoPak Non-invasive Bone Growth Stimulator System and Biomet SpinalPak Non-invasive Spine Fusion Stimulator Sys

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·iSert® Pre-loaded System; IPURE Pre-loaded System; PreVue Pre-loaded System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses, Biomedics 55 Sphere, Biomedics Toric

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

FDA Pre-Market Approval

FDA Class 3 ·PROSTHESIS, HIP, HEMI-FEMORAL, METAL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT 3 (PHEMFILCON A) LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS PC10 & PC21

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL UPB365 POSTERIOR CHAMBER INTRAOCULAR LENSES

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·Gynecare Interceed Absorbable Adhesion Barrier

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·TriVisc®