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

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·ST AIA-PACK PA

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·IMMUNOASAY, PSA

ZOLL M SERIES ETCO2 OPTION

FDA 510(k)
FDA Class 3 ·Cardiovascular

ZOLL PAD WITH CPR AID

FDA 510(k)
FDA Class 3 ·Cardiovascular

ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)

FDA 510(k)
FDA Class 3 ·Cardiovascular

ZOLL M SERIES

FDA 510(k)
FDA Class 3 ·Cardiovascular

ZOLL AED PLUS

FDA 510(k)
FDA Class 3 ·Cardiovascular

ZOLL PAD

FDA 510(k)
FDA Class 3 ·Cardiovascular

ZOLL M SERIES 12SL ANALYSIS OPTION

FDA 510(k)
FDA Class 3 ·Cardiovascular

Hepatitis Delta Serological Reagents

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

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

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

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

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

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·AIA-PACK PSA

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, Test, Alpha-Fetoprotein For Neural Tube Defects

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

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·AIA-PACK PSA

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