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.