689 results · 27ms · Sources: EU EUDAMED, US FDA

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·Open Pivot Heart Valve, Open Pivot Aortic Valved Graft

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·Open Pivot Aortic Valved Graft

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ATS OPEN PIVOT HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·OPEN PIVOT HEART VALVE (OPHV) AND OPEN PIVOT AORTIC VALVED GRAFT (OPAVG)

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·Open Pivot Heart Valve, Open Pivot Aortic Valved Graft, Open Pivot Heart Valve – AP360

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ATS OPEN PIVOT BILEAFLET HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVE GRAFT

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·OPEN PIVOT MECHANICAL HEART VALVES AND OPEN PIVOT AORTIC VALVED GRAFT

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·UV-PMMA PCL'S

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·CoreValve System; CoreValve Evolut R System; CoreValve Evolut PRO System

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·GAMMA DAB (125I) AFP RIA KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·Access AFP Reagents on the Access Immunoassay Systems

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·Atellica IM Alpha Fetoprotein (AFP)

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·ACCESS AFP REAGENTS ON THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AXSYM AFP (LN 7A48)

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·Atellica® IM Alpha Fetoprotein (AFP) Assay

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AFP RIA KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500 AFP

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·ADVIA CENTAUR AFP ASSAY

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE® AFP, IMMULITE® 2000 AFP