EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SONOS AIRES 600 (SA-600)

FDA 510(k)

FDA Class 2 ·Radiology

K.E.E. OXYGEN CONCENTRATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5

FDA 510(k)

FDA Class 2 ·Radiology

SUNDT-KEES REINFORCING ANEURYSM CLIP

FDA 510(k)

FDA Class 2 ·Neurology

REVISED LABELING FOR MODEL CL-0PE ND:YAG LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EXALIS, SOFTWARE VERSION 1.15

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MOLECULAR ADSORBENT RECIRCULATING(MARS)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRISMAFLEX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COMPUTER DYNO/GONIO/MYO GRAPHY

FDA 510(k)

FDA Class 2 ·Physical Medicine

PHOENIX HEMODIALYSIS DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRISMAFLEX SYSTEM 7.10

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology