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

Single Use Injection Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RHYTHMIA HDx™ Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ASTRONOMER PLUS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

INNOCOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

VX1+

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAC 5000 ECG ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMBULATORY (HOLTER) RECORDING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)

FDA 510(k)

FDA Class 2 ·Cardiovascular