2021 Device Approvals | FDA

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 thera sphere™ – P200029 Radiation Treatment 03/17/2021 Elecsys Anti-HBs II, preci control Anti-HBs, Anti-Hbs cal check – P190034 Laboratory Test 02/23/2021 Patient Specific Talus Spacer – H200001 Implant 02/17/2021 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter – P200039 Catheter 02/12/2021 Elecsys Anti-HBe, preci control Anti-HBe – P190005 Laboratory Test 02/03/2021 Restylane Defyne – P140029/S027 Gel Implant 01/29/2021 diamond temp Ablation Catheters - P200028 Catheter 01/28/2021 Imagio® Breast Imaging System – P200003 Ultrasound 01/11/2021
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