KF-E SERIES HOLLOW FIBER DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KF-E SERIES OF HOLLOW FIBER DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEUTRAL RED

FDA 510(k)

FDA Class 1 ·Hematology

AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEDITECH MODEL ABPM-04

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOSPY ECG HOLTER SYSTEMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION

FDA 510(k)

FDA Class 2 ·Radiology

ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS

FDA 510(k)

FDA Class 2 ·Radiology

TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

XBody Go USA, XBody Pro USA

FDA 510(k)

FDA Class 2 ·Physical Medicine

Xbody Newave USA

FDA 510(k)

FDA Class 2 ·Physical Medicine

XBody Go USA, XBody Pro USA

FDA 510(k)

FDA Class 2 ·Physical Medicine

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

MEGATEX PATIENT EXAMINATION GLOVES (LATEX)

FDA 510(k)

FDA Class 1 ·General Hospital

PHOENIX HEMODIALYSIS DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology