1,590 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·CORAB-M
Hepatitis Delta Serological Reagents
FDA Pre-Market Approval
FDA Class 3
·ABBOTT ANTI-DELTA (EIA) ASSAY
System, Test, Tumor Marker, For Detection Of Bladder Cancer
FDA Pre-Market Approval
FDA Class 3
·UroVysion Bladder Cancer Kit
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·Alinity m HBV
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
FDA Pre-Market Approval
FDA Class 3
·Prismaflex TPE2000 Set
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE
Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence
FDA Pre-Market Approval
FDA Class 3
·UroVysion Bladder Cancer Kit
Barrier, Absorbable, Adhesion
FDA Pre-Market Approval
FDA Class 3
·SEPRAFILM ADHESION BARRIER
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
FDA Pre-Market Approval
FDA Class 3
·Prismaflex TPE2000 Set
Barrier, Absorbable, Adhesion
FDA Pre-Market Approval
FDA Class 3
·Seprafilm Adhesion Barrier
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·Preveleak Surgical Sealant, Preveleak 10-Pack delivery Tips
Fluid, Hysteroscopy
FDA Pre-Market Approval
FDA Class 3
·DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM
Barrier, Absorbable, Adhesion
FDA Pre-Market Approval
FDA Class 3
·SEPRAFILM ADHESION BARRIER
Barrier, Absorbable, Adhesion
FDA Pre-Market Approval
FDA Class 3
·ADEPT Adhesion Reduction Solution
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ABBOTT ARCHITECT AUSAB
Barrier, Absorbable, Adhesion
FDA Pre-Market Approval
FDA Class 3
·SEPRAFILM ADHESION BARRIER
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·AXSYM HBSAG/HBSAG CONFIRMATORY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE (LN 6L22)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBSAG QUALITATIVE AND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY
Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence
FDA Pre-Market Approval
FDA Class 3
·Urovysion Bladder Cancer Kit