Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR CHAMBER INTRAOCULAR LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·X-70 SOFT CONTACT LENS

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UPB260S

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Avalus Ultra Bioprosthesis

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock Valved Conduit

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·UroVysion Bladder Cancer Kit

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HBV

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Medtronic Avalus Bioprosthesis

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock Valved Conduit

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL UV95 ULTRAVIOLET LIGHT-ABSORBING LENS (POST)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Bellafil Dermal Filler

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock Valved Conduit

Intraocular Lens

FDA Pre-Market Approval

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