CARTO 3 EP Navigation System Version 7.2

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnSite Precision Cardiac Mapping System v2.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDAID

FDA 510(k)

FDA Class 2 ·Neurology

EnSite Velocity Surface Electrode Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

AVVIGO Guidance System

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEARTSUITE HEMODYNAMICS 7.10

FDA 510(k)

FDA Class 2 ·Cardiovascular

4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A

FDA 510(k)

FDA Class 2 ·Neurology

MEDS-3 NEUROMUSCULAR STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Zio ECG Utilization Software (ZEUS) System

FDA 510(k)

FDA Class 2 ·Cardiovascular

GB-1002 TENS WITH MASSAGE

FDA 510(k)

FDA Class 2 ·Neurology

CATHCOR DESKTOP

FDA 510(k)

FDA Class 2 ·Cardiovascular

Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)

FDA 510(k)

FDA Class 2 ·Cardiovascular

EP MEDSYSTEMS, EP-WORKMATE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Q5000 PC WORKSTATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

DS-200 AND DS-400 T.E.N.S.

FDA 510(k)

FDA Class 2 ·Neurology

HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

VENDYS, MODEL 6000 B B/C

FDA 510(k)

FDA Class 2 ·Cardiovascular

NYNEX II

FDA 510(k)

FDA Class 2 ·Neurology

MODIFICATION TO CARTO EP NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular