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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.

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Hancock Modified Orifice Valved Conduit

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·NATRELLE Saline-Filled Breast Implants

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ESSENTIO™ SR, ESSENTIO™ DR, ESSENTIO™ EL DR, PROPONENT™ SR, PROPONENT™ DR, PROPONENT™ EL DR, ACCOLADE™ SR, ACCOLADE™ DR,

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Drug Eluting Permanent Right Ventricular/Right Atrial Pacemaker Electrodes

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Master Restore, Itrel®, Synergy® and Intellis Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® Spinal

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·LifeStent™ 5F Vascular Stent Systems

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SynchroMed® Infusion System, Ascenda® Intrathecal Catheters

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·Inogen CRT-D; Inogen X4 CRT-D; Dynagen CRT-D; Dynagen X4 CRT-D

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGIFOAM® Absorbable Gelatin Sponge

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery