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

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK IMIPENUM CARD

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 ·SOFT MATE(TM)CONCEPT CLEANING & DISINFECTING SOLUT

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK GRAM POSITIVE SUSCEPTIBILITY FOR OXACILLIN

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFTHERM SOL.

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

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

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

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·E COLI STORAGE CONDITION

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST