PS-41 6M PATIENT SIMULATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LIGHTSOURCE OR ILLUMINATOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AccelFix Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRIMUS VARIANT SYSTEM PVS99

FDA 510(k)

FDA Class 2 ·Hematology

LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

COULTER CARBON DIOXIDE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INFRASONICS VENTILATOR ADULT STAR, MODIFICATION

FDA 510(k)

FDA Class 2 ·Anesthesiology

Neurophet AQUA (V3.1)

FDA 510(k)

FDA Class 2 ·Radiology

PREFORMANCE POSTS AND TEMPORARY CYLINDERS

FDA 510(k)

FDA Class 2 ·Dental

KING-HUE, ROYAL CORAL, SUPER-C ARTIFICIAL TEETH

FDA 510(k)

FDA Class 2 ·Dental

LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEDICAL IMAGE PROCESSING UNIT

FDA 510(k)

FDA Class 2 ·Dental

DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)

FDA 510(k)

FDA Class 2 ·Neurology

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader

FDA 510(k)

FDA Class 2 ·General Hospital

Stabil Orthopaedic Solutions Total Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

SPECTRUM DISIGNS PECTORAL IMPLANT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AMSafe(R) Pre-Filled Normal Saline Flush Syringe

FDA 510(k)

FDA Class 2 ·General Hospital

DIAGNOSTIC ULTRASOUND, MODEL 1.0

FDA 510(k)

FDA Class 2 ·Radiology