Medical Devices

2014 Device Approvals

The products listed in this section include some of the newest medical technology from the year 2014. 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 2014

Device NameCategoryDate
Medtronic IN.PACT Admiral Paclitaxel-coated PTA Balloon Catheter - P140010 Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter 12/30/14
Bellafill PMMA Collagen Dermal Filler - P020012/S009 Dermal filler 12/23/14
BRACAnalysis CDx - P140020 Ovarian Cancer 12/19/14
TECNIS Multifocal 1-Piece Intraocular Lens (IOL), Models ZKB00 (+2.75 D) and ZLB00 (+3.25 D) - P980040/S049 Artificial Lenses 12/17/14
Barostim neo Legacy System - H130007 Implantable Pulse Generator (IPG) 12/12/14
Animas Vibe System - P130007 Glucose Monitoring 11/25/14
IDEAL IMPLANT Saline-filled Breast Implant - P120011 Breast Implants 11/14/14
TactiCath Quartz Contact Force Ablation Catheter and TactiSys Quartz Equipment - P130026 Catheter 10/24/14
Dexcom G4 PLATINUM Continuous Glucose Monitoring System - P120005/S018 Glucose Monitoring 10/21/14
EverFlex Self-Expanding Peripheral Stent System – P110023/S007 Stent 10/10/14
Lutonix 035 Drug Coated Balloon PTA Catheter - P130024 Angioplasty 10/09/14
XIENCE Family of Everolimus Eluting Coronary Stent Systems - P070015/S122 and P110019/S066 Stent 10/03/14
GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface - P040037/S060 Stent 09/19/14
SenoClaire - P130020 Mammography 08/26/14
Pleximmune - H130004 Blood Test 08/26/14
XPS System with STEEN Solution Perfusate - H120003 Lung Transplant 08/12/14
Cologuard - P130017 Stool Test 08/11/14
Low-Profile Visualized Intraluminal Support Device (LVIS and LVIS Jr.) - H130005 Stent 07/25/14
Prestige LP Cervical Disc - P090029 Cervical Disc 07/24/14
REBEL Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) - P130030 Stent 06/27/14
Sorin Freedom SOLO Stentless Heart Valve and SOLO Smart Stentless Heart Valve - P130011 Stentless Heart Valve 06/24/14
Fluency Plus Endovascular Stent Graft - P130029 Endovascular Stent Graft 06/17/14
Edwards SAPIEN XT Transcatheter Heart Valve - P130009 Heart Valve 06/16/14
Restylane Silk Injectable Gel - P040024/S072 Injection 06/13/14
Medtronic CoreValve System - P130021/S002 Aortic Heart Valve 06/12/14
artus CMV RGQ MDx Kit - P130027 Cytomegalovirus (CMV) DNA Test 06/02/14
CardioMEMS HF System - P100045 Pulmonary Artery Pressure 05/28/14
therascreen KRAS RGQ PCR Kit - P110027 Automated Molecular Assay 05/23/14
ADVIA Centaur® HBsAgII - P110041 hepatitis B virus (HBV) 05/16/14
GEL-SYN - P110005 Osteoarthritis 05/09/14
Inspire Upper Airway Stimulation - P130008 Obstructive Sleep Apnea 04/30/14
cobas® HPV Test - P100020/S008 HPV Test 04/24/14
Medtronic CRT-P and CRT-D Devices - P010015/S205 and P010031/S381 Pacemaker/Defibrillator 04/10/14
Supera Peripheral Stent System – P120020 Peripheral Stent 03/28/14
Nucleus® Hybrid™ L24 Cochlear Implant System – P130016 Cochlear Implant System 03/20/14
Elecsys® HBeAg Immunoassay and Elecsys® PreciControl HBeAg - P130015 Hepatitis B Test 03/14/14
MONOVISC™ - P090031 Joints 02/25/14
Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System - P120005/S002 Glucose Monitoring 02/03/14
Medtronic Valiant Thoracic Stent Graft with Captivia Delivery System - P100040/S012 Stent Graft 01/22/14
Medtronic CoreValve System - P130021 Artificial aortic valve 01/17/14
ReSure® Sealant - P130004 Surgical Sealant 01/08/14

Page Last Updated: 07/13/2015
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