491 results · 26ms · Sources: EU EUDAMED, US FDA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD AND MAXIMO VR ICD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·REVO MRI IPG

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE DEVICE, PROCLOSE AT 6F SUTURE MEDIATED CLOSURE SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·6726 Y Adaptor/Extender Kit

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·NOVACOR N100PC LVAS WITH OPTIONAL EPTFE INFLOW CONDUIT

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·EPIC VASCULAR SELF-EXPANDING STENT SYSTEM

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval
FDA Class 3 ·GORE VIATORR TIPS ENDOPROSTHESIS

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation (SNM) System Urinary Control

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation (SNM) System Bowel Control

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval
FDA Class 3 ·Optiguide Cylindrical Fiber Optic

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·MODEL 640011X4 POCKET ADAPTOR FOR DEEP BRAIN STIMULATION;MODEL 64002 2X4 POCKET ADAPTOR FOR DEEP BRAIN STIMULATION

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·MODEL 74001 1X4 POCKET ADAPTOR FOR SPINAL CORD STIMULATION;MODEL 74002 2X4 POCKET ADAPTOR FOR SPINAL CORD STIMULATION

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

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·FLAIR ENDOVASCULAR STENT GRAFT

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·Covera™ Vascular Covered Stent

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

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