ACUFEX LINEAR/ROTARY INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Orthopedic

T3 Software

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRECISION CAPILLARIES FOR MICROMANIPULATION

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

INFINITY MASIMO SET SP02 POD

FDA 510(k)

FDA Class 2 ·Cardiovascular

CYNOSURE PHOTOGENICA SV LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PROSTATIC CORE-CUT NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HEWLETT-PACKARD MODLES 78354A/78352 PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL

FDA 510(k)

FDA Class 2 ·Cardiovascular

EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MICRO SURGICAL SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MITEK ANCHOR(TM)

FDA 510(k)

FDA Class 2 ·Orthopedic

INTRA-SONIX UROFIBER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223

FDA 510(k)

FDA Class 2 ·Neurology

DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HD Lumbar Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ReWalk(TM)

FDA 510(k)

FDA Class 2 ·Physical Medicine