947 results · 19ms · Sources: EU EUDAMED, US FDA

Iliac Covered Stent, Arterial

FDA Pre-Market Approval
FDA Class 3 ·Gore Viabahn VBX Balloon Expandable Endoprosthesis

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim® Sacral Nerve Stimulation Therapy System / Bowel Control

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·MACROPLASTIQUE IMPLANTS

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer Amulet Left Atrial Appendage Occluder

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·SECURE®-C Cervical Artificial Disc

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval
FDA Class 3 ·Augment® Bone Graft

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·Gore VIABAHN ENDOPROSTHESIS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE V, XIENCE NANO,XIENCE PRIME, XIENCE PRIME LONG LESION,XIENCE XPEDITION XIENCE XPEDITION SMALL VESSEL AND XPEDITIO

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE EPI PACING LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Resonate family of CRT-D's

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Zenith Alpha Thoracic Endovascular Graft

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·ORBERA Intragastric Balloon System

Acute Coronary Syndrome Event Detector

FDA Pre-Market Approval
FDA Class 3 ·Guardian System

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·Nucleus 24 Cochlear Implant System

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·Macroplastique Implants

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS®) Liver™

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval
FDA Class 3 ·Eluvia Drug-Eluting Vascular Stent System