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

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·INSTAT COLLAGEN ABSORBABLE HEMOSTAT

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 ·POSTERIOR CHAMBER INTRAOCULAR LENSES

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 HBsAg Immunoassay

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE® VIABAHN® Endoprosthesis

Diagnostic Low Electric Field

FDA Pre-Market Approval

FDA Class 3 ·DUNE MEDICAL DEVICES MARGINPROBE SYSTEM

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 ·TIER A LENS MODELS UPB360GN AND UP320F

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anit-HBc IgM

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900

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 ·MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH FLEX AAA ENDOVASCULAR GRAFT

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP