MODEL EM-2 BIOELECTRIC PROCESSOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

ELECTRIC MUSCLE STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

NEUROMUSCULAR STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

UROGRAM CYSTOMETROGRAM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PATHFAST CK-MB-II, PATHFAST MYO-II

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LABELING FOR MYO/WIRE II STERNOTOMY SUTURES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Certa Catheter

FDA 510(k)

FDA Class 2 ·Anesthesiology

FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2

FDA 510(k)

FDA Class 2 ·Hematology

NURTURE III

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS

FDA 510(k)

FDA Class 2 ·Hematology

THE NURTURE III BREAST PUMP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3

FDA 510(k)

FDA Class 2 ·Hematology

FIBRINOGEN FDP CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry