HORIZON 55 BI-CON

FDA 510(k)

FDA Class 2 ·Ophthalmic

A.X.T. SPOTFILM DEVICE

FDA 510(k)

FDA Class 2 ·Radiology

Bridge Occlusion Balloon

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITAL SYNC SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE

FDA 510(k)

FDA Class 2 ·Physical Medicine

MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR

FDA 510(k)

FDA Class 2 ·General Hospital

DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCI-GUARD MULTI-SAMPLE BLOOD COLLECTION NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

NEW COBE CARDIOPLEGIA SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY-

FDA 510(k)

FDA Class 2 ·Ophthalmic

SURECATH PORT ACCESS CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

FORCE 1C

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PHYSIO HAB

FDA 510(k)

FDA Class 2 ·Physical Medicine

OHMEDA ADAPTABLE CABLE W/DETACHABLE SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000

FDA 510(k)

FDA Class 2 ·Neurology

MLS, ZERONA-AD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Arctic Sun Temperature Management System

FDA 510(k)

FDA Class 2 ·Cardiovascular

LPA-3 PRINTER

FDA 510(k)

FDA Class 2 ·Anesthesiology