SPACER-S

FDA 510(k)

FDA Class 2 ·Orthopedic

ADHOC CLAW

FDA 510(k)

FDA Class 2 ·Orthopedic

BREAST SIMULATION SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

PRECLUDE DURA SUBSTITUTE

FDA 510(k)

FDA Class 2 ·Neurology

IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

IV TRIFURCATED EXTENSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

EDTA GEL (TM)

FDA 510(k)

FDA Class 2 ·Dental

SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

TERUMO ASPRIATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CLEAR POROUS PLASTIC-HYPOALLERGENIC

FDA 510(k)

FDA Class 2 ·Hematology

CAPIOX HEMOCONCENTRATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ONCENTRA-VISIR

FDA 510(k)

FDA Class 2 ·Radiology

CAPIOX SP PUMP HEAD

FDA 510(k)

FDA Class 2 ·Cardiovascular

MCAFFEE UNIVERSAL SPINAL SYSTEM (MUSS)

FDA 510(k)

FDA Class 2 ·Orthopedic

BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE 0.5/0.25-32/16 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

AUTIMO 2.5-D AND AUTIMO 3-D

FDA 510(k)

FDA Class 2 ·Radiology

HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO THE BOLD SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

FDA 510(k)

FDA Class 2 ·Immunology