HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COBE CENTRYSYSTEM 600 HG HEMODIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

aeris Balloon Dialation Catheter

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES

FDA 510(k)

FDA Class 2 ·Cardiovascular

Artix BG

FDA 510(k)

FDA Class 2 ·Cardiovascular

ECG SENTINEL System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ONGUARD 1000, CATALOG #043611-000 & 043611-001

FDA 510(k)

FDA Class 2 ·Cardiovascular

GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO LUNDIA PRO 200 DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FRESENIUS BLOOD VOLUME MONITOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ONE-STEP DOUBLE-CHEK PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COBE CENTRYSYSTEM 14 PES HEMODIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COBE CENTRYSYSTEM CS500 DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CENTRYSYSTEM 3 WITH CHARTS/BP OPTION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

LUMITROL CONTROLLER, LUMITROL HAND-CONTROLLED ELECTROSURGICAL PENCIL WITH BLADE ELECTRODE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FPC HIP STEM COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

BACTTRAP

FDA 510(k)

FDA Class 2 ·Anesthesiology

GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology