System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·MICROSCAN RAPID FLUOROGENIC PANELS

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

Gas Chromatography, Ethosuximide

FDA classification

FDA Class 2 ·Gas Chromatography, Ethosuximide

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M1000 IMAGECHECKER

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·INDERMIL(TM) TISSUE ADHESIVE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK (TM)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-SOAK(R) CONDITIONING SOLUTION ALCON WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID#84392

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-FREE(R) RINSING, DISINFECTING, & STORAGE SOLUTION OPTI-FREE(R) EXPRESS(TM) MULTI-PURPOSE SOLUTION

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·KODAK MAMMOGRAPHY CAD ENGINE

KENS INTERNAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SILICONE ENDOTRACHEAL TUBE

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPERMICIDAL LUBRICATED MALE LATEX CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GLOVES, PATIENT EXAMINATION

FDA 510(k)

FDA Class 2 ·Microbiology

SILICATH ALL SILICONE FOLEY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BLACK COLOURED CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Carex Hybrid Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ENDOTRACHEAL TUBE

FDA 510(k)

FDA Class 2 ·Anesthesiology