Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC COREVALVE (R) SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PROTOS DR/CLS AND PROTOS VR/CLS

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED 3 BLS Device

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED 3 BLS

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED 3 BLS

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·ZOLL AED 3 BLS Device

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·ZOLL AED 3 BLS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARISOLV MINIMAL INVASIVE DENTAL CARIES REMOVAL SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Endurant, EndurantII, Endurant lls Stent Graft Systems

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Endurant, Endurant II, Endurant LLs talent Occluder

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PROTOS DR/CLS, PROTOS VR/CLS, AXIOS DR, AXIOS D, AXIOS S, AXIOS SR, AND AXIOS SLR PULSE GENERATORS WITH PROGRAMMER SOFT

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Endurant, Endurant II, and Endurant lls Stent Graft System

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·BIOTRONIK INOS2+ CLS PULSE GENERATOR AND B-K05.V.U PROGRAMMER SOFTWARE

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION PUMP

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Saluda Medical Evoke SCS System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CYLOS DR, PROTOS DR-CLS, PHILOS 2 DR, PHILOS DR, AXIOS DR

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™