Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

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

Page Last Updated: 01/11/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English