Class III Medical Devices

Class III is the most stringent regulatory category for medical devices.

Class III devices are usually present in applications essential to supporting or sustaining human life and are often instrumental in the maintenance of human health.

For more information on Class III Medical Devices and how to classify your medical device, please visit the U.S. Food and Drug Administration website.

Components for Class III Medical Devices

Examples of Class III implantable medical devices that contain FMI components include:

• Pacemakers
• Defibrillators
• Neurostimulation / Neuromodulation
• Artificial joint implants
• Surgical reconstructive components
• Grafting / Suture points for implanted devices
• Heart pumps / LVAD / VAD
• Urological implants
• Suture sleeves

Click here for a more complete list of applications for our ultra clean silicone components.

Get To Market More Quickly And Cost Effectively

FMI has extensive experience with ultra clean silicone medical products. Let FMI create turnkey solutions for your medical device components.

Call (847) 350-1535 or Contact FMI to discuss your next medical silicone project.