Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT(R) 3 FOR EXT WEAR

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC HBSAG REAGENT PACK CALIBRATOR AND CONFIRMATORY KIT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CIBA VISION LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PUREVISION 2/PUREVISION 2 MULTI-FOCAL/PUREVISION 2 TORIC (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BAUSCH & LOMB SOFTLENS (POLYMACON) CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT(R) 3 FOR EXT WEAR

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

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys HBsAg

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBsAG Qualitative Reagent Kit (100/500 Test), ARCHITECT HBsAG Qualitative Confirmatory Reagent Kit

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX Injectable Gel

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) Assay

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·LensCrafters Monthly, LensCrafters Monthly Modern Lifestyle, LensCrafters Monthly for Astigmatism, LensCrafters Monthly

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE,IMMULITE 1000 HBSAG,CONFIRMATORY AND IMMULITE 2000 HBSAG,CONFIRMATORY KIT

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·Solesta Injectable Gel

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE® 2000 HBsAg and IMMULITE® 2000 HBsAg Confirmatory Kit’