System, Oxygen, Aqueous

FDA Pre-Market Approval

FDA Class 3 ·TherOx Downstream System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEMS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·HeartLight Catheter, HeartLight X3 Console V2

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC-HALL PROSTHETIC HEART VALVE

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System

System, Oxygen, Aqueous

FDA Pre-Market Approval

FDA Class 3 ·TherOx Downstream System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare® Ventricular Assist System

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER THE WIRE RENAL STENT SYSTEM

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER-THE-WIRE RENAL STENT SYSTEM

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·GEM21S Growth Factor Enhanced Matrix

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TREO® Abdominal Stent-Graft System

Agent, Injectable, Embolic

FDA Pre-Market Approval

FDA Class 3 ·Onyx Liquid Embolic System

Implant, Auditory Brainstem

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM

Agent, Injectable, Embolic

FDA Pre-Market Approval

FDA Class 3 ·ONYX LIQUID EMBOLIC SYSTEM

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER DUCT OCCLUDER/DUCT OCCLUDER II

Implant, Auditory Brainstem

FDA Pre-Market Approval

FDA Class 3 ·Necleus Auditory Brainstem Impant System

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER

Agent, Injectable, Embolic

FDA Pre-Market Approval

FDA Class 3 ·ONYX LIQUID EMBOLIC SYSTEM (LES)

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER DUCT OCCLUDER