HDF Assist Mudule, HDF Infusion Set and Substitution Filter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RENAFLO HDF 1350 HEMODIAFILTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)

FDA 510(k)

FDA Class 2 ·Microbiology

THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104

FDA 510(k)

FDA Class 2 ·Anesthesiology

ABI VEST AIRWAY CLEARANCE SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF

FDA 510(k)

FDA Class 2 ·Neurology

SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE

FDA 510(k)

FDA Class 2 ·General Hospital

VASCATH VASCULAR CATHETER PLACEMENT KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

SURECATH-ITP PERCUTANEOUS ACCESS KIT

FDA 510(k)

FDA Class 2 ·General Hospital

VISUALIZER 2000

FDA 510(k)

FDA Class 2 ·Radiology

NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTASE PHE/GAL SCREENING ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

G-EYE System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ambu® aScope™ Colon; Ambu® aBox™ 2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DiLumen Endolumenal Interventional Platform

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FUJINON COLONOSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FUJIFILM Endoscope Models EC-600HL and EC-600LS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology