2,591 results
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24ms
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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 HBsAg/Confirmatory Readypack Reagents, Calibrators and Controls
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BIOMEDICS 38 (POLYMACON) HYDROPHILIC CONTACT LENSES
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
·Biofinity XR Toric and Biofinity Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended wear
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·AQUASEPT II
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR AHBS
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·O2 OPTIX (LOTRAFILCON B) AND NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·COAPTITE Injectable Implant
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Tetrafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·COOPERVISION METHAFILCON A SOFT EXTENDED WEAR CONTACT LENSES
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA Centaur Anti-HBe2 (AHBe2) Assay
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·SOFLENS (POLYMACON) CONTACT LENSES
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
·BIOFINITY
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
·BIO-RAD MONOLISA ANTI-HBS EIA
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
·MONOLISA ANTI-HBC IGM EIA
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·BARD TEGRESS URETHRAL IMPLANT