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

HPM-6000U

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SKOUT® system

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AEON Laparoscopic Instruments

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EMBOSPHERE MICROSPHERES

FDA 510(k)

FDA Class 2 ·Neurology

ANGIOSCOPE

FDA 510(k)

FDA Class 2 ·Cardiovascular

NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/Bridges

FDA 510(k)

FDA Class 2 ·Dental

NEVONI CLASSIC, MODEL 6600-PO

FDA 510(k)

FDA Class 2 ·Anesthesiology

WALDMANN F85/100W UV6

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery