Single Use Injector NM600/610

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AcQMap High Resolution Imaging and Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)

FDA 510(k)

FDA Class 2 ·Cardiovascular

UROPLASTY RIGID ENDOSCOPIC NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CATHWRITER(TM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MUSE CARDIOLOGY INFORMATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8

FDA 510(k)

FDA Class 2 ·Cardiovascular

UROPLASTY RIGID ENDOSCPIC NEEDLES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NM INJECTION NEEDLES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENTERYX INJECTION CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUANTIEN MEASUREMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST

FDA 510(k)

FDA Class 2 ·Cardiovascular

Zio XT ECG Monitoring System, Zio AT ECG Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

KODEX – EPD™ System 1.5.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

THE OPHTHIMUS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

AVVIGO Guidance System II

FDA 510(k)

FDA Class 2 ·Cardiovascular

Epiphany Cardio Server Mobile

FDA 510(k)

FDA Class 2 ·Cardiovascular