U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. Device Approvals, Denials and Clearances
  5. Recently-Approved Devices
  6. 2021 Device Approvals
  1. Recently-Approved Devices

The products listed in this section include some of the newest medical technology from the year 2021. The products in each list contain information about what medical uses the device is cleared or approved for, when it can be used, and when it should not be used. This information, along with information from your doctor and other sources, can help make you an informed participant in your health care.

Medical Devices Cleared or Approved by FDA in 2021

Device Name Category Date
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter – P200039 Catheter 02/12/2021
DiamondTemp Ablation Catheters - P200028 Catheter 01/28/2021
Imagio® Breast Imaging System – P200003 Ultrasound 01/11/2021

 

Subscribe to Recent Device Approvals

Sign up to receive email updates on Recent Device Approvals.

Back to Top