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’

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