2,743 results · 25ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL 721A ULTRAVIOLET LIGHT-ABSORBING LENS (POST)

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS 019B, 019C, 019E, 019F, 019J, & 019K

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

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 & ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·UV-PMMA ALTERNATE VENDOR /UV ABSORBING IOL

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 ·MODELS U260,U360,U360N,U365,U370,&UP383 LENSES

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN Endoprosthesis and 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

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

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