ANTIBODY TO INTRINSIC FACTOR RADIOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

POS-T-VAC (REJOYN VACUUM ERECTION DEVICE)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SUPER PORCELAIN EX-3 PRESS

FDA 510(k)

FDA Class 2 ·Dental

PROSTATE IMMOBILIZER RECTAL BALLOON

FDA 510(k)

FDA Class 2 ·Radiology

KINAMED ATH 26MM COCR TOTAL HIP FEMORAL HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

PAINMASTER MCT PATCH

FDA 510(k)

FDA Class 2 ·Neurology

CATHETER INTRODUCER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATRAUMATIC SPECIAL SPROTTE NEEDLE

FDA 510(k)

FDA Class 2 ·Anesthesiology

TOKUSO LIGHT BOND

FDA 510(k)

FDA Class 2 ·Dental

ESCREEN SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AUTOLAP SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KOTEX STICK TAMPONS, REGULAR AND SUPER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471

FDA 510(k)

FDA Class 2 ·Cardiovascular

RANGEROLLER

FDA 510(k)

FDA Class 2 ·Physical Medicine

CYPRESS SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

DSS STABILIZATION SYSTEM-RIGID

FDA 510(k)

FDA Class 2 ·Orthopedic

TECHNIQUE, CHROMATOGRAPHIC, HEMOGLOBIN

FDA 510(k)

FDA Class 2 ·Hematology

FPR CARBAMAZEPINE KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

KOTEX PROFILE SHAPED MAXI PAD

FDA 510(k)

FDA Class 1 ·Obstetrics/Gynecology