EPICARDIA

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMARTFLOW PULSE TRANSMISSION COEFFICIENT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ECHOCOM, IMAGECOM, DOKUCOM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CardioDay V2.5

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CATH LAB AUTOMATED INTERACTIVE RECORDER SYSTEMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pure EP

FDA 510(k)

FDA Class 2 ·Cardiovascular

CardioInsight Cardiac Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Disposable Sclerotherapy Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

Volta AF-Xplorer

FDA 510(k)

FDA Class 2 ·Cardiovascular

LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEEDLE CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYNEFLASH & SYNEVIEW

FDA 510(k)

FDA Class 2 ·Cardiovascular

HORIZON XVU

FDA 510(k)

FDA Class 2 ·Cardiovascular

STAR Apollo Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular