2,591 results
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18ms
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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
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HB REAGENT PACK & CALIBRATORS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·BIO-RAD MONOLISA ANTI-HBC IGM EIA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·PureVision (balafilcon A) Contact Lens
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-EBK PLUS Assay
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BAUSCH & LOMB MEDALIST TORIC (LIDOFILCON A) LENSES
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys Anti-HBc II
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BAUSCH & LOMB SILSOFT (ELASTOFILCON A) CONTACT LENS
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·QUASEPT II
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-MAK-2 Plus Assay
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·AQUASEPT II
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·MENICON SF-P (MELAFOCON A) CONTACT LENS
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·VISTAKON (senofilcon A) ACUVUE OASYS® Brand Contact Lenses.
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-EBK PLUS assay
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·CUSTOMEYES(TM) 45L&55L (BUFILCON A)
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·COAPTITE INJECTABLE IMPLANT