Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS PC10 & PC21

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS MODELS T505/T510

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·LIDOFILCON A HYDROPHILIC CONTACT LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL UPB350S POSTERIOR CHAMBER INTRAOCULAR LENS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·AMO(R) VITRAX(R) VISCOELASTIC SOLUTION

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK MODIFIED ORIFICE VALVED CONDUIT

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Avalus™ Bioprosthesis

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·M-70 (LIDOFILCON A) HYDROPHILIC CONTACT LENS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Bioprosthesis

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·HEALON D SODIUM HYALURONATE SOLUTION

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL UPB350FS UV/ABSORBING POSTERIOR CHAMBER IOL

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT MODEL 150

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·AMO VITRAX (SODIUM HYALURONATE) VISCOELASTIC SOLUTION

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK MODIFIED ORIFICE VALVED CONDUIT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SAUFLON(R) PW (LIDOFILCON B)

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK MODIFIED ORIFICE (MO) VALUED CONDUIT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AC10 & AC20 IOLS