BONNER BRACE

FDA 510(k)

FDA Class 1 ·Physical Medicine

ON-LINE ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

4D MV-ASSESSMENT 2.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

KODEX EPD System

FDA 510(k)

FDA Class 2 ·Cardiovascular

LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITALOG PMS-8 MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

RHYTHMVIEW (TM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MARS HOLTER ANALYSIS WORKSTATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

CERVICAL PILLOW

FDA 510(k)

FDA Class 1 ·Physical Medicine

LOCALISA CARDIAC NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CENTRA II ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

RHYTHMIA HDx Mapping System (with software Version 2.0)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Sensis

FDA 510(k)

FDA Class 2 ·Cardiovascular

HOLTER 6000

FDA 510(k)

FDA Class 2 ·Cardiovascular

HORIZON ANGIO CATHLAB

FDA 510(k)

FDA Class 2 ·Cardiovascular

HOLTER FOR WINDOWS

FDA 510(k)

FDA Class 2 ·Cardiovascular

DeepRhythmAI

FDA 510(k)

FDA Class 2 ·Cardiovascular

STAR Apollo™ Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular