TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

STIMUPLEX-DIG-RC NERVE STIMULATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

THE BIG EASY Y-ADAPTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIG BAG 3000 PRESSURE INFUSOR

FDA 510(k)

FDA Class 2 ·General Hospital

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC BIG RANGER PTCA CATHETER

J-TIP INJECTOR SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Wiygul Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER)

FDA 510(k)

FDA Class 2 ·Anesthesiology

IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CENTRAL VENOUS CATHETER W/BIG-GARD

FDA 510(k)

FDA Class 2 ·Cardiovascular

ALLERG-E IGE ENZYME IMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

V-TREND DIG ENZYME IMMUNOASSAY TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Philips CT Big Bore Sliding Gantry Configuration

FDA 510(k)

FDA Class 2 ·Radiology

SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

OR SPECIFIC BIG CASE BACK TABLE COVER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PROLITE PULSED LIGHT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AMBULATORY ECG DIGITAL MONITOR MODEL: TD-30

FDA 510(k)

FDA Class 2 ·Cardiovascular

DEBP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology