IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT

FDA 510(k)

FDA Class 2 ·Microbiology

eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K

FDA 510(k)

FDA Class 2 ·Ophthalmic

Synchro SELECT Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

Smart Wedge algorithm

FDA 510(k)

FDA Class 2 ·Cardiovascular

IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDIVISION CYSTOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DYNAMO

FDA 510(k)

FDA Class 2 ·Physical Medicine

Precice Ankle Salvage System

FDA 510(k)

FDA Class 2 ·Orthopedic

MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

NAOMI-CT

FDA 510(k)

FDA Class 2 ·Radiology

KARL STORZ TRACHEAL HIGH FREQUENCY RESECTOSCOPE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TI. ALLOY 2.0 MM CORTEX SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

MENTOR INFUSION LINE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PETERS CARDIOFLON(TM) SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AliveCor Heart Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

URITEK TC-201 URINE CHEMISTRY TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Ascendra Balloon Aortic Valvaloplasty Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ComboCath OTW PTA Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

LAPAROLITH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology