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