QUICKSTART UREA NITROGEN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

S2 FEMORAL NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR

FDA 510(k)

FDA Class 2 ·Microbiology

FC-100 FEMORAL CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMMA LOCKING NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS

FDA 510(k)

FDA Class 2 ·Orthopedic

SCEPTOR DATA MANAGEMENT CENTER SOFTWARE

FDA 510(k)

FDA Class 2 ·Microbiology

ADD'L SOFTWARE VERSION D2 FOR MAGNETOM 42 AND 63

FDA 510(k)

FDA Class 2 ·Radiology

LIFESTYLE 55 (OCUFILCON D) HYDROPHILIC CONTACT LENS LIFESTYLE FREQUENCY 55 (OCUFILCON D) GHYDROPHILIC CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

OSTEO BOS SYSTEM PRODUCT LINE EXTENSION

FDA 510(k)

FDA Class 2 ·Orthopedic

ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VIEWMATE ULTRASOUND IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

SHUNTCHECK (PROMETHEUS 1)

FDA 510(k)

FDA Class 2 ·Neurology

HOFFMANN II MRI EXTERNAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)

FDA 510(k)

FDA Class 2 ·Immunology

HUNTLEIGH ALPHACARE, HM95 ALTERNATING PRESS-PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

THIN FILM DRESSING FOR ULTRASOUND EXAM

FDA 510(k)

FDA Class 2 ·Radiology

STAGO FACTOR V-DEFICIENT PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

PLAYTEX EMBRACE PETITE BREAST PUMP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology