Medical Devices

2016 Device Approvals

The products listed in this section include some of the newest medical technology from the year 2016. 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 2016

Device NameCategoryDate
Dexcom G5 Mobile Continuous Glucose Monitoring System - P120005/S041 Glucose Monitoring 12/20/16
AMPLATZER PFO Occluder - P120021 Heart 10/28/16
The 670G System - P160017 Glucose Monitoring 09/26/16
VisuMax® Femtosecond Laser - P150040 Surgical Laser 09/13/16
Obalon Balloon System - P160001 Weight-Loss System 09/08/16
Edwards SAPIEN XT Transcatheter Heart Valve - P130009/S057 Aortic Heart Valve 08/18/16
Edwards SAPIEN 3 Transcatheter Heart Valve - P140031/S010 Aortic Heart Valve 08/18/16
CyPass® System (Model 241-S) - P150037 Glaucoma 07/29/16
ExAblate 4000 Type 1.0 System – P150038 MRI/Ultrasound 07/11/16
Absorb GT1™ Bioresorbable Vascular Scaffold (BVS) System - P150023 Stent 07/05/16
Raindrop® Near Vision Inlay - P150034 Corneal Implant 06/29/16
iPro2 Continuous Glucose Monitoring System - P150029 Glucose Monitoring 06/17/16
AspireAssist - P150024 Obesity 06/14/16
cobas® EGFR Mutation Test v2 - P150047 Molecular Assay 06/01/16
Bard LifeStent Vascular Stent System - P070014/S037 Stent 05/31/16
Juvéderm Volbella® XC – P110033/S018 Dermal Filler 05/31/16
VENTANA PD-L1(SP142) Assay - P160002 Bladder Cancer 05/18/16
ImageReady MR Conditional Pacing System - P150012 Pacing System 04/25/16
Micra Transcatheter Pacemaker System - P150033 Pacemaker 04/06/16
Axium Neurostimulator System – P150004 Neurostimulator 02/26/16
Blazer Open-Irrigated Ablation Catheter- P150005 Ablation Catheter 02/24/16
Closer Vascular Sealing System - P150022 Vascular seal 02/12/16
PD-L1 IHC 28-8 pharmDx - P150027 Lab Test 01/22/16
Sorin Perceval Sutureless Heart Valve - P150011 Heart Valve 01/08/16
Storz Medical Duolith SD1 Shock Wave Therapy Device – P080028 Shock Wave Therapy 01/08/16
Integra Omnigraft Dermal Regeneration Matrix - Interactive Wound Dressing - P900033/S042 Dermal Graft 01/07/16

Page Last Updated: 02/08/2017
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