ETEST SUBMISSION FOR AZITHROMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

SYSTEM, IMAGE PROCESSING

FDA 510(k)

FDA Class 2 ·Radiology

GE DATEX-OHMEDA ENGSTROM CARESTATION

FDA 510(k)

FDA Class 2 ·Anesthesiology

The Optimotion Blue Total Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

C0-AXIAL INTRODUCER NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GUIDANT AXIUS CORONARY SHUNT

FDA 510(k)

FDA Class 2 ·Cardiovascular

3DI

FDA 510(k)

FDA Class 2 ·Radiology

SPIRIT, MODEL HAS

FDA 510(k)

FDA Class 2 ·Anesthesiology

Arrow 0.2 Micron Flat Filter, GVS

FDA 510(k)

FDA Class 2 ·Anesthesiology

EPIC Extremity Fracture Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

POPS! one Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GE DATEX-OHMEDA ENGSTROM CARESTATION

FDA 510(k)

FDA Class 2 ·Anesthesiology

LODE COAGULOMETER MODEL LC-6

FDA 510(k)

FDA Class 2 ·Hematology

WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS

FDA 510(k)

FDA Class 2 ·Radiology

ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM

FDA 510(k)

FDA Class 2 ·Orthopedic

MFI-Cardiac

FDA 510(k)

FDA Class 2 ·Radiology

EPIC Extremity Snap-Off Screw

FDA 510(k)

FDA Class 2 ·Orthopedic

RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)

FDA 510(k)

FDA Class 2 ·General Hospital

ROTATING GAMMA SYSTEM. GAMMA ART-6000

FDA 510(k)

FDA Class 2 ·Radiology