1,338 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Implant, Corneal, Refractive
FDA Pre-Market Approval
FDA Class 3
·INTACS PRESCRIPTION INSERTS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AUSAB
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBsAg Next Qualitative / Next Confirmatory
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AUSAB
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AUSAB (LN 1L82)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
FDA Pre-Market Approval
FDA Class 3
·PRISMA TPE 2000 SET
System, Hemodynamic, Implantable
FDA Pre-Market Approval
FDA Class 3
·Cordella Pulmonary Artery Sensor System (CorPASS)
Implant, Corneal, Refractive
FDA Pre-Market Approval
FDA Class 3
·INTACS CORNEAL IMPLANTS
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·Preveleak Surgical Sealant
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBSAG QUALITATIVE CONFIRMATORY , LN 4P54
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE-M (LN 6L23)
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·ABBOTT REALTIME HBV
Absorbable Collagen Hemostatic Agent With Thrombin
FDA Pre-Market Approval
FDA Class 3
·Floseal hemostatic Matrix
Barrier, Absorbable, Adhesion
FDA Pre-Market Approval
FDA Class 3
·SEPRAFILM
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·Coseal Surgical Sealant
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·AXSYM AUSAB (LN 3C74)
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ABBOTT AXSYM AFP
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AFP (LN 3P36)
Barrier, Absorbable, Adhesion
FDA Pre-Market Approval
FDA Class 3
·ADEPT Adhesion Reduction Solution