Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·AMVISC AND AMVISC PLUS OPHTHALMIC VISCOSURGICAL DEVICE

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF IQ RESTOR IOLS 3.0 AND 4.0 D ADD POWERS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINITY (COMFILCON A) Soft (Hydrophilic) Contact Lenses

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRESTIGE LP Cervical Disc

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFTCON(R) (VIFILCONA)

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL JM19UB POSTERIOR CHAMBER IOL

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·LASAG TOPAZ ND:YAG LASER SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Sphere, Biofinity Toric, Biofinity Multifocal, Biofinity Energys, Biofinity Sphere XR

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

FDA Pre-Market Approval

FDA Class 3 ·OSTEO CERAMIC HIP

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity XR Toric and Biofinity Toric Multifocal comfilcon A Soft (Hydrophilic) Contact Lenses

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 727A POSTERIOR CHAMBER INTRAOCULAR LENSES

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·HEALON DUET DUAL PACK

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Preset Tips

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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