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FDA Class III Medical Devices

View 10000 FDA Class III Medical Devices on BEUDAMED, the Better Database on Medical Devices. These high‑risk devices typically sustain or support life, are implanted, or present a potential unreasonable risk of illness or injury and therefore require Premarket Approval (PMA) by the US FDA. BEUDAMED provides concise entries that highlight regulatory status, indications for use, and approval history to aid regulatory and clinical research.

FDA Class III devices often include implantable cardiac devices, heart valves, and certain long‑term life‑support systems that rely on clinical evidence for market authorization. Manufacturers must provide robust clinical data, post‑market surveillance plans, and comply with adverse event reporting and quality system requirements to maintain approval. BEUDAMED’s summaries make it easier to locate regulatory milestones and postmarket obligations for these critical device categories.

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Stockert 70 Radio Frequency Ablation Generator

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval
FDA Class 3 ·EGFR pharmDx

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·Arctic Front Advance Pro Cryoballoon Catheter

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

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

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

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·Inspire Model 4323 Sensing Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Ingevity Lead Family (passive fixation models)

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·Oxford Partial Knee System

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval
FDA Class 3 ·MiSight 1 day (omafilcon A)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II M4, PROTECTA CRT-D, PROTECTA M4, PROTECTA XT CRT-D, PROTECTA XT M4