1,984 results · 20ms · Sources: EU EUDAMED, US FDA

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

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Zenith AAA Endovascular Graft

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL UPB385 POSTERIOR CHAMBER INTRAOCULAR LENS

System, Endovascular Graft, Aortic Aneurysm Treatment

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

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

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® Iliac Branch

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·BIODIVYSIO OC/SV OTW STENT DELIVERY SYSTEMS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL AC10 & AC20 IOLS

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

FDA Pre-Market Approval
FDA Class 3 ·Oxford® Partial Knee System

Diagnostic Low Electric Field

FDA Pre-Market Approval
FDA Class 3 ·MarginProbe System

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

FDA Pre-Market Approval
FDA Class 3 ·Oxford Partial Knee System

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 ·Conformable GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

Intraocular Lens

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

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

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

FDA Pre-Market Approval
FDA Class 3 ·Elecsys Anti-HBc IgM