FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ablamap® System

FDA 510(k)

FDA Class 2 ·Cardiovascular

PICOCLAMP

FDA 510(k)

FDA Class 2 ·Cardiovascular

FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO EP NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

LIFEPATCH ECG ELECTRODES

FDA 510(k)

FDA Class 2 ·Cardiovascular

IREX CARDIOPLAN

FDA 510(k)

FDA Class 2 ·Cardiovascular

HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85

FDA 510(k)

FDA Class 2 ·Cardiovascular

REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMPLANTABLE BIPOLAR CARDIAC PULSE GEN

FDA 510(k)

FDA Class 3 ·Cardiovascular

UNIPOLAR ATRIAL J PACING LEAD MODEL 869

FDA 510(k)

FDA Class 3 ·Cardiovascular

OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOPULMONARY BYPASS PUMP TUBING

FDA 510(k)

FDA Class 2 ·Cardiovascular

INJECTOR FILL TUBE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)

FDA 510(k)

FDA Class 2 ·Cardiovascular

560

FDA 510(k)

FDA Class 2 ·Cardiovascular

SERVOMED PULSE AMPLIFIER MODULE-206-

FDA 510(k)

FDA Class 2 ·Cardiovascular

MDP2000 MEDICAL DATA PROCESSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

SHELHIGH NO-REACT PERICARDIAL PATCHES

FDA 510(k)

FDA Class 2 ·Cardiovascular