ACE(TM) CEDIA(R) PHENYTOIN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TERUMO RADIFOCUS GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

DELFIA(TM) CORTISOL KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CHAMPY BONE PLATES & BONE SCREWS

FDA 510(k)

FDA Class 2 ·Dental

EYE TRAY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARDIOPHONICS MEMORY TRANSMITTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOBEEPER(R) III

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY

FDA 510(k)

FDA Class 1 ·Microbiology

MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET

FDA 510(k)

FDA Class 2 ·Orthopedic

BD PROBE TEC URINE PRESERVATIVE TRANSPORT

FDA 510(k)

FDA Class 2 ·Microbiology

IMT LOUPE-COLPOSCOPE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ANTIBACTERIAL GUTTA PERCHA

FDA 510(k)

FDA Class 1 ·Dental

CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615

FDA 510(k)

FDA Class 2 ·Anesthesiology

LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE

FDA 510(k)

FDA Class 1 ·General Hospital

MODIFICATION TO FOX PTA CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

HARWILL MEDICAL CERVITULA CERVICAL SPATULA

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

KMW HIP PROSTHESIS POROUS COATED

FDA 510(k)

MINIOX V PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPHERZ

FDA 510(k)

FDA Class 2 ·Neurology

SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE

FDA 510(k)

FDA Class 2 ·Anesthesiology