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
Bausch + Lomb ULTRA (samfilcon A) Contact Lenses - P170035 Contact Lens 04/30/18
PartoSure Test - P160052 PAMG-1 Test 04/30/18
Medtronic DBS System for Epilepsy - P960009/S219 Epilepsy 04/27/18
Medtronic IN.PACT™ Admiral™ Paclitaxel-Coated PTA Balloon Catheter - P140010/S037 Catheter 04/19/18
ThinPrep Integrated Imager - P950039/S036 Cervical Cancer 04/18/18
AngelMed Guardian System - P150009 Cardiac Monitor 04/09/18
FoundationFocus CDxBRCA LOH - P160018/S001 Ovarian Cancer 04/06/18
GORE® CARDIOFORM Septal Occluder - P050006/S060 Heart Implant 03/30/18
TransMedics, Inc. TransMedics OCS Lung System – P160013 Lung preservation system 03/22/18
LIPOSORBER® LA-15 System - H170002 Cholesterol 03/20/18
Guardian Connect System – P160007 Glucose Monitor 03/08/18
Abbott Perclose ProGlide Suture-Mediated Closure System - P960043/S097 Suture 02/16/18
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
Lifeline/ReviveR ECG and DDU Automated Defibrillators - P160032 Defibrillators 02/01/18
Aptima HBV Quant assay - P170025 HBV Test 01/28/18

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Page Last Updated: 05/17/2018
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