Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AcrySof IQ ReSTOR Intraocular Lenses

Fluid, Hysteroscopy

FDA Pre-Market Approval

FDA Class 3 ·DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD, Sotlec I, Softec HD PS, Softec HDO, Softec HDM

Electrosurgical, Radio Frequency, Refractive Correction

FDA Pre-Market Approval

FDA Class 3 ·VIEWPOINT CONDUCTIVE KERATOPLASTY SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·LCS Total Knee System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Pure Vision (balafilcon A) Visibility Tinted Soft (hydrophillic) Contact Lens

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS U260,U360,U360N,U365,U370,&UP383 LENSES

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PERMALENS EXTENDED WEAR CONTACT LENS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Cerene Cryotherapy Device

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT(R)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT 3 (PHEMFILCON A) UV OPTIFIT TORIC AND SPHERICAL CONTACT LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SUPARTZ

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS 019B, 019C, 019E, 019F, 019J, & 019K

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE

Electrosurgical, Radio Frequency, Refractive Correction

FDA Pre-Market Approval

FDA Class 3 ·VIEWPOINT CK 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 LUMBAR TAPERED FUSION DEVICE

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES