8,260 results
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22ms
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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
·ADVIA CENTAUR HBSAGII (HBSII);ADVIA CENTAUR XP HBSAG CONFIRMATORY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Atellica IM Hepatitis B e Antigen (HBeAg)
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·METHAFILCON A AND METHAFILCON B SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·IMMULITE/IMMULITE 1000 AFP and IMMULITE 2000 AFP
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·SOFLENS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE CALIBRATOR
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Soflens 38 (polymacon) Visibility Tinted Contact Lenses
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·B AND L 70 LIDOFILCON A CONTACT LENSE
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·ANTERIOR CHAMBER IOL'S
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODEL 91-50 IOL
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·FREQUENCY TORIC & SPHERE (METHAFILCON A 55%) SOFT (HYDROPHILIC) CONTACT LENSES
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BAUSCH & LOMB SOFLENS (POLYMACON) CONTACT LENS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS Anti-HBc
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·FREQUENCY XCEL TORIC XR
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Atellica IM Hepatitis B e Antigen (HBeAg)