ICON TELERADIOLOGY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Catamaran SI Joint Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

SPAPLUS

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6

FDA 510(k)

FDA Class 2 ·Immunology

MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

REVISED DOUBLE ANTIBODY AMPHETAMINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ELECTRONIC MUSCLE STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP.

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EXTERNAL FETAL MONITOR TRANSDUCER HOLDER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ELECTRO-NERVE STIMULATOR DISCO B9 TENS

FDA 510(k)

FDA Class 2 ·Neurology

BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

FDA 510(k)

FDA Class 2 ·Dental

IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS)

FDA 510(k)

FDA Class 2 ·Immunology

MILENIA(TM) CANNABINOIDS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MODEL 545-45 LASER FOR EAR, NOSE & THROAT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG

FDA 510(k)

FDA Class 2 ·Orthopedic

HEMOSTATIC SIDEARM

FDA 510(k)

FDA Class 2 ·Cardiovascular

ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5

FDA 510(k)

FDA Class 2 ·Immunology

DIO STEADY EXTERNAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental