Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF RESTOR INTRAOCULAR LENS

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval

FDA Class 3 ·PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS 3-Piece Acrylic Monofocal

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CHAMBER LENS MODELS 101, 101B, 101T

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval

FDA Class 3 ·TRULIGN TORIC WEB-BASED TORIC CALCULATOR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BAUSCH & LOMB SOFTLENS (POLYMACON) CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-flex lntraocular Lens, C-flex Aspheric lntraocular Lens, 6.0 mm Aspheric lntraocular Lens, and RayOne Aspheric

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF INTRAOCULAR LENSES (IOLS)

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) WAVESCAN WAVEFRONT SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SM-1, CR-1, & GR-1 IOLS

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·LIAISON QuantiFERON - TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HC2 SYSTEM SOFTWARE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT(R) 3 FOR EXT WEAR

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·ESSURE PERMANENT BIRTH CONTROL SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys HBsAg

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·KREMER LASER SYSTEM