Alfapump System

FDA Pre-Market Approval

FDA Class 3 ·alfapump System

Alfapump System

FDA Pre-Market Approval

FDA Class 3 ·alfapump System

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Cardiva VASCADE MVP XL Venous Vascular Closure System (VVCS)

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ManaFuse

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NCP Model 201 Programming Wand, VNS Therapy AspireHC Model 105 Generator, VNS Therapy AspireSR, Model 106 Generator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Pedi-padz Multifunction Electrodes, Pro-padz Cardiology W/LVP Gel Electrodes, Pro-padz Radiolucent Liquid Gel Electrodes

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Vascular Closure System (VCS)-VASCADE 5F Vascular Closure System, VASCADE 6/7F Vascular Closure System, VASCADE MVP Veno

ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY

FDA 510(k)

FDA Class 3 ·Cardiovascular

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE TIGIRIS Vascular Stent

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·LifeStent Vascular Stent Systems

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SP,Z,Z NOVUS,SP NOVUS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE TIGRIS Vascular Stent

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·EverFlex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·LIFESTENT VASCULAR STENT SYSTEMS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·BARD LIFESTENT VASCULAR STENT SYSTEM

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·STELIX/STELIX II STEROID ELUTING PACING LEADS; EASYTURN/EASYTURN ACCESSORY SYTLET KITS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Gore Viabahn Endoprosthesis