NIVP3 (WINDOWS VERSION OF NIVP

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2

FDA 510(k)

FDA Class 2 ·Cardiovascular

CER-S

FDA 510(k)

FDA Class 2 ·Cardiovascular

WorkMate Claris System

FDA 510(k)

FDA Class 2 ·Cardiovascular

LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZEUS (ZIO ECG Utilization Service) System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MCKESSON CARDIOLOGY ECG MOBILE

FDA 510(k)

FDA Class 2 ·Cardiovascular

RhythmView Workstation

FDA 510(k)

FDA Class 2 ·Cardiovascular

Globe® Pulsed Field System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZYMED HOLTER SCANNER MODEL 2010

FDA 510(k)

FDA Class 2 ·Cardiovascular

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software License

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cardiovascular Suite 4.2.1

FDA 510(k)

FDA Class 2 ·Cardiovascular

NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENSITE VELOCITY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Vektor Computational ECG Mapping System (vMap)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENSITE VELOCITY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIAC PERFORMANCE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

RADIANALYZER, MODEL 12710

FDA 510(k)

FDA Class 2 ·Cardiovascular