AMBULATORY (HOLTER) RECORDING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Merge Hemo, Model RCSV2

FDA 510(k)

FDA Class 2 ·Cardiovascular

OFF-LINE ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

AcQMap High Resolution Imaging and Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENSITE VELOCITY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

GENYX FLEXIBLE INJECTION NEEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Sentry WEB SmartInterp

FDA 510(k)

FDA Class 2 ·Cardiovascular

UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4

FDA 510(k)

FDA Class 2 ·Cardiovascular

COMBISON COMPUTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENSITE FUSION DYNAMIC REGISTRATION TOOL

FDA 510(k)

FDA Class 2 ·Cardiovascular

EPICARDIA LE/FD

FDA 510(k)

FDA Class 2 ·Cardiovascular

Rhythm View Workstation (non-streaming)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affera Integrated Mapping System; Impedance Localization Patch Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 5650C CARDIOLOGY DATA MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

GUIDED MEDICAL POSITIONING SYSTEM (GMPS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

AVOXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular