IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6

FDA 510(k)

FDA Class 2 ·Microbiology

Integrated CardioRespiratory System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ELECTRO-NERVE STIMULATOR TENS MODEL C & B11, B11C

FDA 510(k)

FDA Class 2 ·Neurology

OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EMC MODEL NO. STATOME 900

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TIO-H DIGITAL RADIOGRAPHY SENSOR

FDA 510(k)

FDA Class 2 ·Dental

DIGITAL IMAGER

FDA 510(k)

FDA Class 2 ·Radiology

MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CAUTION CONDOMS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VIRTUSO SYSTEM FOR IHC (DO-7)

FDA 510(k)

FDA Class 2 ·Hematology

COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

NEO-THOR THORACOSTOMY KIT

FDA 510(k)

FDA Class 2 ·General Hospital

INFUSION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ULTRA RENEW PLUS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Hubble II

FDA 510(k)

FDA Class 2 ·Orthopedic

ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

COAT-A-COUNT(TM) FENTANYL (TKFN1)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

A.V. FISTULA NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology