Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·CHARITE ARTIFICIAL DISC

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer II XP Cardiac Ablation Catheter and Cable

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Chilli II Cooled Ablation Catheter and Cable

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·Express SD Monorail Premounted Stent Systemt

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer Open Irrigated Temperature Ablation Catheter

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Blazer II Cardiac Ablation Catheter and Cable

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Sphere, Biofinity Toric, Biofinity Multifocal, Biofinity Energys, Biofinity Sphere XR

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL® Absorbable Hemostats

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Hydro Thermablator Endometrial Ablation System

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Epic Vascular Self-Expanding Stent System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Innova Self-Expanding Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN 2000+ LOW INTENSITY FRACTURE HEALING SYSTEM

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN 4000+BONE HEALING SYSTEM

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN 2000+

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN 3000

Cap, Cervical, Contraceptive

FDA Pre-Market Approval

FDA Class 3 ·PRENTIF TM CAVITY RIM CERVICAL CAP