49 results · 20ms · Sources: EU EUDAMED, US FDA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SECURA DR/VR, VIRTUOSO II DR/VR AND MAXIMO II DR/VR

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·CONSULTA CRT-D, CONCERTO II CRT-D AND MAXIMO II CRT-D

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT AFP-EIA

Kit, Assay, Estrogen Receptor

FDA Pre-Market Approval
FDA Class 3 ·ER-EIA MONOCLONAL

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval
FDA Class 3 ·PGR-EIA MONOCLONAL

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

FDA Pre-Market Approval
FDA Class 3 ·MONOLISA ANTI-HBS EIA

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT PGR-EIA MONOCLONAL

Hepatitis Delta Serological Reagents

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT ANTI-DELTA EIA

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

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT HBE (RDNA) EIA

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval
FDA Class 3 ·ADEZA FETAL FIBRONECTIN EIK

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

FDA Pre-Market Approval
FDA Class 3 ·MONOLISA ANTI-HBC EIA

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

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT HBE (RDNA) EIA

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval
FDA Class 3 ·ADEZA FETAL FIBRONECTIN EIK

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT PGR-EIA MONOCLONAL

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

FDA Pre-Market Approval
FDA Class 3 ·MONOLISA ANTI-HBS EIA

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval
FDA Class 3 ·NOVOTTF-100A SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·MONOLISA ANTI-HBC IGM EIA

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

FDA Pre-Market Approval
FDA Class 3 ·MONOLISA ANTI-HBC IGM EIA

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT AFP-EIA DIAGNOSTIC KIT

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval
FDA Class 3 ·BIOTRIN PARVOVIRUS IGM EIA (V619IMUS)