Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS PC-43,44,45 NB UV ABSORBING IOL

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II BIOPROSTHETIC HEART VALVE

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VITRAX OPHTHALMIC SURGICAL AID

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 721A ULTRAVIOLET LIGHT-ABSORBING LENS (POST)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS PC10 & PC21

Intraocular Lens

FDA Pre-Market Approval

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS, MODELS T505 AND T510

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock II Bioprosthesis

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-PMMA ALTERNATE VENDOR /UV ABSORBING IOL

Intraocular Lens

FDA Pre-Market Approval

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

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AC10 & AC20 IOLS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS- (MODELS T505, T510)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL UP350 UV/ABSORBING POSTERIOR CHAMBER IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 721A ULTRAVIOLET LIGHT-ABSORBING LENS (POST)

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Mosaic Bioprosthesis & Mosaic Ultra Bioprosthesis