Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·INSPIRIS RESILIA Aortic Valve, MITRIS RESILIA Mitral Valve

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·GFX 2 OVER-THE-WIRE CORONARY STSENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MICRO STENT TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MICRO STENT TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·GFX-XP/GFX2 CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·GFX & MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·GFX OVER-THE-WIRE CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·GFX SL OVER-THE-WIRE CORONARY STENT SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·Guardian Glucose Sensor (3)

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·Guardian Glucose Sensor (3)

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Guardian Glucose Sensor (3)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME REVEL SYSTEM

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM

Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA Pre-Market Approval

FDA Class 3 ·DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM(R)