ELISIO-H HEMODIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRISMAFLEX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ALTREX 110 HEMODIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HEMOCOR HPH MINI HEMOCONCENTRATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Tablo Console

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Tablo® Hemodialysis System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULTRX(TM) 850 ARTIFICIAL KIDNEY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NxStage Therapeutic Plasma Exchange (TPE) Cartridge

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AQUADEX FLEXFLOW SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NXSTAGE 1.6M2 DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STREAMLINE EXPRESS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BLOOD CONCENTRATOR 140

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO LUNDIA MAJOR HIGH FLUX HEMODIALYZ

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology