2,597 results · 35ms · Sources: EU EUDAMED, US FDA

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Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT CORE-M

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS

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 ·Frequency 55 (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ADVIA Centaur® and Atellica IM Hepatitis B Core IgM (AHBcM) Assay

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·COAPTITE INJECTABLE IMPLANT

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·SOLESTA INJECTABLE GEL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY ENERGYS ASPHERE, BIOFINITY XR TORIC, BIOFINITY XR MULTIFOCAL

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT CORE-M

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ANTI-HBC IMMULITE SUBSTRATE REAGENT

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT HBSAG/CONFIRMATORY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY TEST AND ELECSYS PRECICONTROL HBSAG

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT HBsAg Qualitative/HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative/HBsAg Qualitative Confirmatory

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·B AND L 70 LIDOFILCON A CONTACT LENSE

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT CORE-M / Alinity i Anti-HBc IgM

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 ·ARCHITECT HBSAG QUALITATIVE (LN 4P53), 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 ·IMMULITE® 2000 Anti-HBc

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·8IGNATURE CONTACT LENS