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

2008T BlueStar Hemodialysis Machine

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRISMA SYSTEM R03.10A

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RENAFLO HDF 1350 HEMODIAFILTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COBE CENTRYSYSTEM 700 HG HEMODIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PSN HEMODIALYZER, MODELS PSN 170, PSN 210

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology