Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·PROVISC™ Ophthalmic Viscosurgical Device

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·LensCrafters Monthly, LensCrafters Monthly Modern Lifestyle, LensCrafters Monthly for Astigmatism, LensCrafters Monthly

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IOLAB SUREFIT MODELS 85JS, 85JM & 85JL ANTERIOR

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES,MODEL C11UB

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 PHARMDX

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VITRAX SODIUM HYALURONATE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AKREOS POSTERIOR CHAMBERS INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-FLEX MODEL 570C INTRAOCULAR LENS (IOL)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOMEDICS 38 (POLYMACON) HYDROPHILIC CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT/DUOVISC Ophthalmic Viscoelastic System

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas EGFR Mutation Test, Roche cobas DNA Sample Preparation Kit

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval

FDA Class 3 ·UROVYSION BLADDER CANCER KIT

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses

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 for Extended wear

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL IMPLANTABLE COLLAMER LENS (VISIAN ICL)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5 PRODUCTS

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) REBBIT MONOCLONAL PRIMARY ANTIBODY