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

FDA 510(k)

FDA Class 2 ·Radiology

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

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

FDA 510(k)

FDA Class 2 ·General Hospital

Thin Layer Chromatography, Phenobarbital

FDA classification

FDA Class 2 ·Thin Layer Chromatography, Phenobarbital

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

Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

FDA Pre-Market Approval

FDA Class 2 ·NEODYMIUM-YAG OP LASER OPL-3

Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

FDA Pre-Market Approval

FDA Class 2 ·NEODYMIUM-YAG OP LASER OPL-3

Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

FDA Pre-Market Approval

FDA Class 2 ·NEODYMIUM-YAG OP LASER OPL-3

DEX Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CALCIUM REAGENT SYS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry