Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFTLENS CLEANING AND SOAKING SOL.

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·GAS PERMEABLE COMFORTCARE(TM)WETTING/SOAKING SOLUT

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFT MATE COMFORT DROPS

Device, Vascular, For Promoting Embolization

FDA Pre-Market Approval

FDA Class 2 ·MINI BALLOON

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 ·ALLERGAN PRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOSTON LENS(R) CLEANER

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·AMS CEFOTETAN CARD

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR AMPICILLIN

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·WESLEY-JESSEN (R) WJD-1 MULTI-PURPOSE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·CLARIS(TM) REWETTING DROPS

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

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OTI-05 & LATHE-40 (POLYMACON) LATHE-CUT HYDROPHILI

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·ENDURANCE BONE CEMENT

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY

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

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HCV TEST

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·MC CUE PLC CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM

Discs, Elution

FDA Pre-Market Approval

FDA Class 2 ·AMIKACIN ELUTION DISK FOR AUTOBAC