NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NXSTAGE PUREFLOW SOLUTION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NxStage Therapeutic Plasma Exchange (TPE) Cartridge

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

NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NXSTAGE PREMIXED DIALYSATE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NxStage Cartridge Express with Speedswap

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NxStage System One Plus

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NxStage PureFlow Solution

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NXSTAGE SYSTEM ONE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200

FDA 510(k)

FDA Class 2 ·General Hospital

VersiHD with GuideMe software

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NXSTAGE SYSTEM ONE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology