10,000 results · 50ms · Sources: EU EUDAMED, US FDA

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE(R) AND CAPSURE(R)SP LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC CAPSURE(R) SP MODEL 5024M/5524M PACING LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE SP/SENSE/SP NOVUS

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·PHILOS PACING SYSTEM

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·PHILOS DR-T PULSE GENERATOR

Transvenous Temporary Phrenic Nerve Stimulator

FDA classification
FDA Class 3 ·Transvenous Temporary Phrenic Nerve Stimulator

Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

FDA classification
FDA Class 3 ·Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

Placental Alpha Microglobulin-1 Immunoassay

FDA classification
FDA Class 3 ·Placental Alpha Microglobulin-1 Immunoassay

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery System

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval
FDA Class 3 ·WALLSTENT™ Endoprosthesis

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Solo Smart Stentless Heart Valve

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Durata and Optisure HV Active Steroid Eluting Cardiac Leads

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Implantable Cardioverter Defibrillator ICDs

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·cobas HBV Test

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·Oxford Partial Knee System

Stent, Iliac Vein

FDA Pre-Market Approval
FDA Class 3 ·Venovo Venous Stent System