AVVIGO'+ Multi-Modality Guidance System

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUINTON STATUS 1000

FDA 510(k)

FDA Class 2 ·Cardiovascular

AcQMap High Resolution Imaging and Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cordiana Dx16

FDA 510(k)

FDA Class 2 ·Cardiovascular

HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

PREDICTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

VitalRhythm

FDA 510(k)

FDA Class 2 ·Cardiovascular

TM eCloud ECG Analysis System

FDA 510(k)

FDA Class 2 ·Cardiovascular

DUALTHERM(R) CARDIAC OUTPUT COMPUTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOSTATION-100 (CS-100)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIODAY, VERSION 2.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL IM1000 INTEGRATED MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

CardioInsight Cardiac Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPACELABS MEDICAL ECG ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

RESTRAINT, PROTECTIVE

FDA 510(k)

FDA Class 1 ·Physical Medicine