Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·LOTRAFILCON SOFT CONTACT LENSES FOR EXTENDED WEAR

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

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

FDA Pre-Market Approval

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFLENS

Catheter, Balloon, Transcervical

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·MINERVA ENDOMETRIAL ABLATION SYSTEM

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SYNVISC

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BAUSCH & LOMB PUREVISION (BALAFILCON A) SOFT CONTACT LENS

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·PHYSIO-STIM AND SPINAL-STIM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS, AO60, M160

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·Raindrop® Near Vision Inlay

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent® Trabecular Mjcro-Bypass Stent System, Model GTS100

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AMO TECNIS LENS MODEL ZA9003

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

FDA Pre-Market Approval

FDA Class 3 ·MBT TIBIAL TRAY

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

FDA Pre-Market Approval

FDA Class 3 ·Infuse Bone Graft

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·ESSURE SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·NEUGRAFT