Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY Anti-c-KIT (9.7) 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

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

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

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Bellafill Dermal Filler

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·Inform HER2 Dual ISH DNA Probe Cocktail

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 720M ULTRAVIOLET LIGHT-ABSORBING LENS (POST)

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK 1 STANDARD BIOPROSTHETIC VALVE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL UPB385 POSTERIOR CHAMBER INTRAOCULAR LENS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Bellafill Dermal Filler

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AC10 & AC20 IOLS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MMR RxDx Panel, VENTANA ANTI-MLH1 (M1), VENTANA ANTI-MSH6 (SP93), VENTANA ANTI-MSH2 (G219-1129), VENTANA ANTI-PM

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)

Intraocular Lens

FDA Pre-Market Approval

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

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK LOW POROSITY CONDUIT MODEL 105