System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·POWERLINK SYSTEM

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·CraniSeal Dural Sealant

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SpF Implantable Spinal Fusion Stimulators

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·CELT ACD VASCULAR CLOSURE DEVICE

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIRxcell CoCr Coronary Stent on RX System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIS SYSTEM

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIS SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STYLES 30 & 31 POSTERIOR CHAMBER IOLS

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ENDOLOGIX POWERLINK SYSTEM, VISIFLEX IS DELIVERY SYSTEM

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·DUROLANE

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·CraniSeal Dural Sealant

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TRIVASCULAR, INC OVATION ABDOMINAL STENT GRAFT SYSTEM, TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIRFLEX PREMOUNTED CORONARY STENT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX ENDOVASCULAR AAA SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX ENDOVASCULAR AAA DELIVERY SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Alto Abdominal Stent Graft System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·OVATION ABDOMINAL STENT GRAFT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE 2100 SYSTEM