Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CHIROFLEX(TM)MODEL C10UB ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS

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

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Hepatitis B surface Antigen II (HBsll), Atellica IM Hepatitis B surface Antigen 11 Confirmatory (HBsll Conf)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFLENS CONTACT LENSES (POLYMACON)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

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

Intraocular Lens

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·METHAFILCON B SOFT HYDROPHILIC CONTACT LENSES

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR AND VISION SHAPING TREATMENT

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS ANTI-HBC IGM ASSAY

Aortic Stent

FDA Pre-Market Approval

FDA Class 3 ·NuDel Delivery System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BAUSCH + LOMB Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens

Intraocular Lens

FDA Pre-Market Approval

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

Intraocular Lens

FDA Pre-Market Approval

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENS