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

LOCALISA CARDIAC NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CENTRA II ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Repris Bladder Injection System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RHYTHMIA HDx Mapping System (with software Version 2.0)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Injection Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Disposable Injection Needle AF series

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PORGES SCLEROTHERAPY NEEDLES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

AcQMap High Resolution Imaging and Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Single Use Injector

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ST80I STRESS TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular