Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock Valved Conduit, Model 105

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

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

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Bellafill Dermal Filler

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·CLOSER VASCULAR SEALING SYSTEM

Covered Stent Vascular Connector, Hemodialysis Access Circuit

FDA Pre-Market Approval

FDA Class 3 ·EndoForce Connector for Endovascular Venous Anastomosis

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval

FDA Class 3 ·URO VYSION BLADDER CANCER KIT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS UB308E AND UB350ES

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK PORCINE BIOPROSTHESIS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Bellafill Dermal Filler

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1 (SP263) ASSAY

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock Valved Conduit Low Porosity

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HBV Assay

Artificial Heart

FDA Pre-Market Approval

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

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VITRAX OPHTHALMIC SURGICAL AID

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock Valved Conduit MO