Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·FLEXLENS (HEFILCON A) SOFT CONTACT LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·KONTUR SOFT (METHAFILCON A) LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TECHNICON-38 (POLYMACON) HYDROPHYLIC LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·KONTUR SOFT (METHAFILCON A) LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·KONTUR SOFT (METHAFILCON A) LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·KONTUR SOFT (METHAFILCON A) LENS

ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

TROKEL SINGLE MIRROR YAG LASER LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit

FDA 510(k)

FDA Class 2 ·Microbiology

AFFYMETRIX GENE PROFILING REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SOFT LENS THERMAL DISINFECTING UNIT, A-C

FDA 510(k)

FDA Class 2 ·Ophthalmic

PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480

FDA 510(k)

FDA Class 2 ·Ophthalmic

SHIELDS T.C. LASER LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

CONTACT LENS OPHTHALMODYNAMOMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

BD MAX CDIFF ASSAY, BD MAX INSTRUMENT

FDA 510(k)

FDA Class 2 ·Microbiology

TROKEL /3 GONIO LASER LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

IRIS ND:YAG OPTHALMIC LASER

FDA 510(k)

FDA Class 2 ·Ophthalmic

cobas Cdiff nucleic acid test for use on the cobas Liat System

FDA 510(k)

FDA Class 2 ·Microbiology

CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology