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  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
Simplify® Cervical Artificial Disc – P200022/S003 Implant 04/01/2021
Medtronic Harmony Transcatheter Pulmonary Valve (TPV) System – P200046 Catheter 03/26/2021
ClearVisc Ophthalmic Viscosurgical Device – P200025 Ophthalmic Device 03/23/2021
TheraSphere™ – P200029 Radiation Treatment 03/17/2021
Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBsCalCheck – 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, PreciControl Anti-HBe – P190005 Laboratory Test 02/03/2021
AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE) – P190013 Battery 02/02/2021
Restylane Defyne – P140029/S027 Gel Implant 01/29/2021
DiamondTemp Ablation Catheters - P200028 Catheter 01/28/2021
Imagio® Breast Imaging System – P200003 Ultrasound 01/11/2021


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