BIOSENSOR HOLTER MONITOR SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Williams Cystoscopic Injection Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CoroFlow Cardiovascular System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO RMT EP NAVIGATION SYSTEM V8

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCUSTRESS EXERCISE TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

4D LV-ANALYSIS 3.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)

FDA 510(k)

FDA Class 2 ·Cardiovascular

COMPUTER ASSISTED ARCHIVAL TECH. PHYSIOLOGY STAT.

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADVANCED UROSCIENCE INJECTION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DYE CURVE EVALUATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: RADIANALYZER, MODEL 12711

FDA 510(k)

FDA Class 2 ·Cardiovascular

SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION OF NOGA

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOSOFT/CASE CARDIAC TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

HeartKey® Rhythm

FDA 510(k)

FDA Class 2 ·Cardiovascular

WINDSURFER

FDA 510(k)

FDA Class 2 ·Cardiovascular

GALIX WINTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ERBELIFT HAND PUMP AND FLEXIBLE PROBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology