CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2

FDA 510(k)

FDA Class 2 ·Cardiovascular

AcQMap High Resolution Imaging and Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Disposable Endoscope Injection Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)

FDA 510(k)

FDA Class 2 ·Cardiovascular

VX1

FDA 510(k)

FDA Class 2 ·Cardiovascular

iLab Polaris Multi-Modality Guidance System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2

FDA 510(k)

FDA Class 2 ·Cardiovascular

EP-STAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

RESPIEVENTS, VERSION 4.2

FDA 510(k)

FDA Class 2 ·Cardiovascular

AI-ECG Platform

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affera Integrated Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO CARTO EP NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENSITE VELOCITY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOMARC COAXIAL NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CH 2000 CARDIAC DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARRHYTHMIA II EDITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MT-200

FDA 510(k)

FDA Class 2 ·Cardiovascular