BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS

FDA 510(k)

FDA Class 2 ·Anesthesiology

IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

DOUBLE LUMEN CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 10200 PREMATURE INFANT INCUBATOR

FDA 510(k)

FDA Class 2 ·General Hospital

SIM 4000I

FDA 510(k)

FDA Class 2 ·Radiology

WHITESIDE ORTHOLOC II REV POST STAB TOTAL KNEE SY

FDA 510(k)

FDA Class 2 ·Orthopedic

COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

PLATELET AGGREGATION REAGENTS

FDA 510(k)

FDA Class 2 ·Hematology

EDWARDS ORTHOPAEDICS ARTHROSCOPES AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Orthopedic

LIFE-LINE(TM) VASCULAR ACCESS SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

35 WATT SURGICAL CARBON DIOXIDE LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COLTENE RAPID

FDA 510(k)

FDA Class 2 ·Dental

PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODEL 5866-37M LEAD ADAPTOR KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

SICKLE CELL REAGENT SET

FDA 510(k)

FDA Class 2 ·Hematology

GE SIGNA ADVANTAGE

FDA 510(k)

FDA Class 2 ·Radiology

ANA-ENZYME IMMUNOASSAY (ANA-EIA) DIAGNOSTIC KIT

FDA 510(k)

FDA Class 2 ·Immunology