Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·BJORK-SHILEY CARDIAC VALVE

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG Thoracic Endoprosthesis

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AC10 & AC20 IOLS

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170

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)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG Thoracic Endoprosthesis product family

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AC10 & AC20 IOLS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·Oxford Partial Knee System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV/ABSORBING POSTERIOR CHAMBER IOL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·X-70 SOFT CONTACT LENS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis and Gore VIABAHN Endoprosthesis with Heparin Endoprosthesis

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBc IgM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH FLEX AAA ENDOVASCULAR GRAFT

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM