GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0

FDA 510(k)

FDA Class 2 ·Radiology

OXYGEN DELIVERY MEASURING DEVICE

FDA 510(k)

FDA Class 1 ·Anesthesiology

MODIFICATION TO CONTOUR SE MICROSPHERES

FDA 510(k)

FDA Class 2 ·Neurology

FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4

FDA 510(k)

FDA Class 2 ·Orthopedic

FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5

FDA 510(k)

FDA Class 2 ·Orthopedic

A BREAST COIL FOR THE GYREX 2T-DIX

FDA 510(k)

FDA Class 2 ·Radiology

VOLUME NECK COIL FOR THE GYREX V-DIX

FDA 510(k)

FDA Class 2 ·Radiology

airVata™

FDA 510(k)

FDA Class 2 ·Dental

GENTLE COLON (REVISION 2.0)

FDA 510(k)

FDA Class 2 ·Radiology

FERTILITY FORECASTER COMPUTER PROGRAM

FDA 510(k)

FDA Unclassified ·Unknown

WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H)

FDA 510(k)

FDA Class 2 ·General Hospital

BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF

FDA 510(k)

FDA Class 2 ·Cardiovascular

HE-30 GOLD

FDA 510(k)

FDA Class 2 ·Cardiovascular

CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALL

FDA 510(k)

FDA Class 1 ·Obstetrics/Gynecology

CERVICAL DILATOR

FDA 510(k)

FDA Class 1 ·Obstetrics/Gynecology

FIXED-SIZE UTERINE DILATOR

FDA 510(k)

FDA Class 1 ·Obstetrics/Gynecology

CERVICAL DILATORS:PRATT,HAWKIN,KLEEGMAN,DENNISTON

FDA 510(k)

FDA Class 1 ·Obstetrics/Gynecology