Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UPB260S

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·SIMPSON CORONARY ATHEROCATH(R) SCA-EX DEVICE

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·COOK CHORIONIC VILLUS SAMPLING (CVS) SET

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 ANTI-HBC IGM ON COBAS E 601

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 HEMOSTAT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IGM TEST SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBc IgM

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·VIABAHN ENDOPROSTHESIS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

Diagnostic Low Electric Field

FDA Pre-Market Approval

FDA Class 3 ·MarginProbe System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·SIMPSON CORONARY ATHEROCATH(TM),SCA-EX(TM), SCA-EX 7 FRENCH GRAFT AND ATHEROCATH-GTO(R)

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·BJORK-SHILEY CARDIAC VALVE

Intraocular Lens

FDA Pre-Market Approval

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

Intraocular Lens

FDA Pre-Market Approval

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