Stent Graft, Bypass, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·DETOUR System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·EluNIR Ridaforolimus Eluting Coronary Stent System

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval

FDA Class 3 ·I-FACTOR PEPTIDE ENHANCED BONE GRAFT

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·Filshie Clip (Mark VI) System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Ovation iX Abdominal Stent Graft System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·EluNIR™ Ridaforolimus Eluting Coronary Stent System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIRxcell CoCr Coronary Stent on RX System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Defibtech Automated External Defibrillator (AED) Systems

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Ovation iX Abdominal Stent Graft System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX ENDOVASCULAR AAA SYSTEM

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SPF-4 IMPLANTABLE BONE GROWTH STIMULATOR

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIRXCELL COCR CORONARY STENT ON RX

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PRESILLION PLUS COCR CORONARY STENT RX SYSTEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Defibtech Automated External Defibrillator (AED) Systems

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval

FDA Class 3 ·I-FACTOR PEPTIDE ENHANCED BONE GRAFT

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIRXCELL COCR CORONARY STENT ON RX

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SpF® Implantable Spinal Fusion Stimulators

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·OL 1000, OL 1000 SC, AND SPINALOGIC BONE GROWTH STIMULATORS

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SpF Implantable Spinal Fusion Stimulators