IBED WIRELESS WITH IBED AWARENESS

FDA 510(k)

FDA Class 2 ·General Hospital

iBed Wireless with iBed Mobile

FDA 510(k)

FDA Class 2 ·General Hospital

PIONEER PRO-PUMP DUAL CONTROL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PIONEER PRO-PUMP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

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

STUART CD UNIVERSAL ROD CONNECTOR CLAMPS

FDA 510(k)

FDA Class 2 ·Orthopedic

FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

Vlab

FDA 510(k)

FDA Class 2 ·Neurology

ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

Bladeless Trocar; Bladed Trocar; Hasson Trocar

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRISMAFLEX M150 SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology