This is a high-tech specialty focused on the heart and circulatory system. The FDA has a dedicated division for these devices .
Diagnostic Equipment: ECG/EKG machines, Holter monitors, blood pressure monitors, and stress test systems .
Interventional & Surgical: Cardiac stents, angioplasty catheters, guidewires, and vascular grafts .
Implantable Devices: Pacemakers, implantable defibrillators (ICDs), and artificial heart valves .
Accessories: Electrodes, leadwires, and cables for diagnostic monitors .
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