USFDA CDRH - List of Medical Devices Cleared/Approved in the 2014...

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 Name	Category	Date
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