MT-200

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOSENSOR HOLTER MONITOR SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CoroFlow Cardiovascular System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO RMT EP NAVIGATION SYSTEM V8

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCUSTRESS EXERCISE TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

4D LV-ANALYSIS 3.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)

FDA 510(k)

FDA Class 2 ·Cardiovascular

COMPUTER ASSISTED ARCHIVAL TECH. PHYSIOLOGY STAT.

FDA 510(k)

FDA Class 2 ·Cardiovascular

DYE CURVE EVALUATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: RADIANALYZER, MODEL 12711

FDA 510(k)

FDA Class 2 ·Cardiovascular

SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

OTI BONE CEMENT PLUG

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION OF NOGA

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOSOFT/CASE CARDIAC TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

HeartKey® Rhythm

FDA 510(k)

FDA Class 2 ·Cardiovascular

WINDSURFER

FDA 510(k)

FDA Class 2 ·Cardiovascular

GALIX WINTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO EP NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

DeepRhythmAI

FDA 510(k)

FDA Class 2 ·Cardiovascular