Katalyst Training System

FDA 510(k)

FDA Class 2 ·Physical Medicine

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

ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WALDMANN F85/100W UV6

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENTERAL FEEDING PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMPRINT ABLATION SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

K-ASSAY C1-INA

FDA 510(k)

FDA Class 2 ·Immunology

SEAL RITE PROCEDURE KIT(TM)

FDA 510(k)

FDA Class 2 ·Dental