491 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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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