Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·TITAN MEGA AND TITAN MEGA XL

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·TITAN MEGA AND TITAN MEGA XL PTCA DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·TITAN MEGA AND TITAN MEGA XL PTCA DILATATION CATHETERS

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Multifunctional Ablation Generator (MAG)

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Multifunctional Ablation Generator (MAG)

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·MISAGO RX Self-expanding Peripheral Stent

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LifeVest Wearable Defibrillator

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA)

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER DUCT OCCLUDER

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·MICROSULIS MICROWAVE ENDOMETERIAL ABLATION (MEA) SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER AND AMPLATZER MULTIFENESTRATED SEPTAL OCCLUDER-CRIBRIFORM

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER DUCT OCCLUDER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity (comflicon A)