Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Cerene® Cryotherapy Device

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Synergy IOL with TECNIS Simplicity Delivery System, TECNIS Synergy Toric II IOL with TECNIS Simplicity Delivery S

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS TORIC 1-PIECE INTRAOCULAR LENSES (IOLS) EXTENDED CYLINDER RANGE (ECR), MODELS ZCT450, ZCT525 AND ZCT600

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE

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

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·HYALGAN®

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ActaStim-S Spine Fusion Stimulator

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·FETAL ACOUSTIC STIMULATOR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFLENS (POLYMACON) VISIBILITY TINTED CONTACT LENS

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SPF IMPLANTABLE SPINAL FUSION STIMULATORS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT

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

FDA Pre-Market Approval

FDA Class 3 ·NexGen® LPS-Flex / LPS Mobile Bearing Knee System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·prodisc® L

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·Gynecare Interceed Absorbable Adhesion Barrier

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

FDA Pre-Market Approval

FDA Class 3 ·Infuse Bone Graft

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO Sil-Ol 5000 Silicone Oil