Medical Devices

2018 Device Approvals

The products listed in this section include some of the newest medical technology from the year 2018. 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 2018

Device NameCategoryDate
MiniMed 630G System with SmartGuard - P150001/S021 Glucose Monitor 02/13/18
MiniMed 670G System - P160017/S017 Glucose Monitor 02/13/18
BD Onclarity HPV Assay - P160037 HPV Test 02/12/18
Impella Ventricular Support Systems - P140003/S018 Heart Pump 02/07/18
Aptima HBV Quant assay - P170025 HBV Test 01/28/18

Page Last Updated: 03/12/2018
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