Glucose Oxidase, Glucose

FDA Pre-Market Approval

FDA Class 2 ·GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER D

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS FRESH(TM) LUBRICATING & REWETTING SOLN

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLICOR HCV TEST AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST VERSION 2.0

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALLERGAN(R) PRESERVED SALINE SOL.SPEC CHANGE

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·AMMENDMENT TO E. COLI ASC

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·SGP LENS(TM)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFT MATE(R) LENS DROPS

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·DEPUY 1 BONE CEMENT

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ENZYME/ SURFACTANT TABLET

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER (CAD) SYSTEM, M100

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS PLUS(TM)

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·RGP CONTACT LENS,SGP (TELE A),SGP II(TELE B)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·0URACLEAN(TM) DAILY CLEANER

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·GAS PERMEABLE CONTACT LENSES

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALLERGAN(R) PRESERVED SALINE SOL.SPEC CHANGE

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·RIGID GAS PERMEABLE CONTACT LENSES

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFTHERM SOL.

Device, Vascular, For Promoting Embolization

FDA Pre-Market Approval

FDA Class 2 ·MINI-BALLOON DETACHABLE BALLOON SYSTEM