Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·INSIGHTEC EXABLATE SYSTEM

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE SYSTEM

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·INSIGHTEC EXABLATE SYSTEM

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE 2100 SYSTEM

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·Exablate 2100/2100 VI System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Endurant Stent Grafyt System, Endurant II Stent Graft System, Ednurant II AUI Stent Graft System, Endurant IIs Stent Gra

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM CGM

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE(R) AND CAPSURE(R) SP SILICONE PACING LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX(R) MODEL 4068 PACING LEAD

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) CAPSURE(R) NOVUS STEROID ELUTING, BIPOLAR, TRANSVENOUS PACING LEAD MODELS 5054 AND 5554

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE Z NOVUS/CAPSURE SP NOVUS TRANSVENOUS TINED PACING LEADS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·S7 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE/RAPID EXCHANGE CORONARY STENT SYSTEM