Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFLENS

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·HYMOVIS® (High Molecular Weight Viscoelastic Hyaluronan)

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS Total Knee System

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·OCUCOAT (2% HYDROXYPROPYLMETHYLCELLULOSE)

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

FDA Pre-Market Approval

FDA Class 3 ·ND:YAG POSTERIOR CAPSULOTOMY MODEL 100

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEES

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SYNVISC & SYNVISC-ONE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CHIROFLEX(TM) SINGLE PIECE SILICONE POST. CHAM.IOL

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML

Reherniation Reduction Device

FDA Pre-Market Approval

FDA Class 3 ·Barricaid Anular Closure Device

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·AME BONE GROWTH STIMULATOR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Multifocal Toric II Intraocular Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·NEW VUES (TM)(VIFILCON A)(HYDROPHILIC)SOFT LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·KELMAN(TM) OMNIFIT II MODEL 2100

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·Superion™ Indirect Decompression System (IDS)

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·Light Adjustable Lens, Light Delivery Device

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ANTERIOR CHAMBER INTRAOCULAR LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CUSTOMEYES(TM) 45L&55L (BUFILCON A)

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

FDA Pre-Market Approval

FDA Class 3 ·Oxford Partial Knee System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Minerva Endometrial Ablation System