EndoPATx

FDA 510(k)

FDA Class 2 ·Cardiovascular

QIVA

FDA 510(k)

FDA Class 2 ·Cardiovascular

V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO® 3 EP Navigation System with Signal Processing Unit

FDA 510(k)

FDA Class 2 ·Cardiovascular

Navik 3D

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnSite Velocity Cardiac Mapping System v5.2

FDA 510(k)

FDA Class 2 ·Cardiovascular

PhysCade System

FDA 510(k)

FDA Class 2 ·Cardiovascular

QRS-CARD CARDIOLOGY SUITE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENSITE 3000 SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Interject Injection Therapy Needle Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NeuTrace EP Mapping System v.2.1

FDA 510(k)

FDA Class 2 ·Cardiovascular

EP-WORKMATE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPACELABS-GENERAL SYSTEM LINK

FDA 510(k)

FDA Class 2 ·Cardiovascular

FusedCO Algorithm

FDA 510(k)

FDA Class 2 ·Cardiovascular

PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE

FDA 510(k)

FDA Class 2 ·Cardiovascular

WASHING/INJECTION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AcQMap High Resolution Imaging and Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology