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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.

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·LUMAX 6/7 AND ILESTO/IFORIA ICD/CRT D FAMILIES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CHILLI COOLED ABLATION SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·THERAPY COOL PATH ABLATION CATHETER & IBI 1500T9

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSATHESIS WITH C3 DELIVERY SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG, ENPULSE E1 IPG,ENPULSE E2 IPG, KAPPA D(KAPPA 700)IPG, KAPPA D(K

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval
FDA Class 3 ·MODEL 2090 MEDTRONIC CARELINK PROGRAMMER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC VIRTUOSO MODEL D154AWG/ D154VWC IMPLANTABLE DEVICES

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·MODELS H115 AND H119 CONTAK CD 2 (CRT-D) CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEM