Smart Wedge algorithm

FDA 510(k)

FDA Class 2 ·Cardiovascular

RHYTHMIA MAPPING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

RhythmAnalytics

FDA 510(k)

FDA Class 2 ·Cardiovascular

KardiaAI

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENSITE VELOCITY SYSTEM V1.3

FDA 510(k)

FDA Class 2 ·Cardiovascular

EP-WORKMATE WITH RPM SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

COMPUSTRESS STRESS TESTING SYS

FDA 510(k)

FDA Class 2 ·Cardiovascular

N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CardioConfirm

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nuubo Smart

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZEUS System (Zio Watch)

FDA 510(k)

FDA Class 2 ·Cardiovascular

AUTOMATED PHYSIOLOGIC PROFILER

FDA 510(k)

FDA Class 2 ·Cardiovascular

EPICARDIA

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMARTFLOW PULSE TRANSMISSION COEFFICIENT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ECHOCOM, IMAGECOM, DOKUCOM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CardioDay V2.5

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CATH LAB AUTOMATED INTERACTIVE RECORDER SYSTEMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pure EP

FDA 510(k)

FDA Class 2 ·Cardiovascular