10,000 results
·
45ms
·
Sources: EU EUDAMED, US FDA
Transcatheter Septal Occluder
FDA Pre-Market Approval
FDA Class 3
·GORE CARDIOFORM ASD Occluder
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE VIABAHN Endoprosthesis product family abd GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Medtronic CoreValve System
Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS) Lung System
Prosthesis, Spinous Process Spacer/Plate
FDA Pre-Market Approval
FDA Class 3
·X-STOP INTERSPINOUS DECOMPRESSION SYSTEM
Stent, Renal
FDA Pre-Market Approval
FDA Class 3
·RX HECULINK ELITE RENAL STENT SYSTEM
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
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·PROMUS ELEMENT PLUS EVEROLIMUS PLATINUM CHRONIUM CORONARY STENT SYSTEM
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·DRIVER AND MICRODRIVER CORONARY STENT SYSTEMS
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·MOBI-C CERVICAL DISC PROSTHESIS
Prosthesis, Spinous Process Spacer/Plate
FDA Pre-Market Approval
FDA Class 3
·Superion Indirect Decompression System
Prosthesis, Ankle, Uncemented, Non-Constrained
FDA Pre-Market Approval
FDA Class 3
·SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·CYPHER SIROLIMUS-ELUTING CORONARY STENT
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·Mentor MemoryShape Breast Implants
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
Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
FDA Pre-Market Approval
FDA Class 3
·Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·CentriMag Circulatory Support System