Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN ABILITY/ABILITY PLUS/ABILITY STRAIGHT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PROTECTA DR/PROTECTA VR/PROTECTA XT DR/PROTECTA XT VR

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·SOLESTA

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·PERFLURON

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE (+) Lidocaine Dermal Filler

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer and IntellaNav/MiFi Open-Irrigated Ablation Catheters

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Itrel®, Synergy® and Intellis Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vectris® Spinal Cord Stimulati

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System

Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence

FDA Pre-Market Approval

FDA Class 3 ·eCoin Peripheral Neurostimulator

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·VALIANT THORACIC STENT GRAFT WITH CAPTIVA DELIVERY SYSTEM

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·THERAKOS CELLEX / THERAKOS UVAR XTS PHOTOPHERESIS SYSTEMS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Butylated Hydroxytoluene (BHT)

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROPACE RNS SYSTEM

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·GAMBRO FIBER PLASMAFILTER

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·cobas HPV

Prosthesis, Finger, Constrained, Metal/Polymer

FDA Pre-Market Approval

FDA Class 3 ·TOTAL TRAPEZIO METACARPAL PROSTHESIS