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Medical Devices

2013 Device Approvals

The products listed in this section include some of the newest medical technology from the year 2013. 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 2013

Device NameCategoryDate
Therapy™ Cool Flex™ Ablation Catheter and IBI 1500T9-CP v.1.7 Cardiac Ablation Generator - P110016/S008 [ARCHIVED] Catheter 12/18/13
GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin BioActive Surface - P130006 [ARCHIVED] Stent 12/05/13
RNS® System - P100026 [ARCHIVED] Epilepsy 11/14/13
MitraClip Clip Delivery System – P100009 [ARCHIVED] Heart valve device 10/24/13
Juvéderm Voluma XC - P110033 [ARCHIVED] Implant 10/22/13
Nidek EC-5000 Excimer Laser System - P970053/S011 [ARCHIVED] LASIK 09/30/13
Wavelight ALLEGRETTO WAVE® Eye-Q Excimer Laser - P020050/S012 [ARCHIVED] LASIK 09/27/13
DIAMONDBACK 360® Coronary Orbital Atherectomy System - P130005 [ARCHIVED] Stent delivery system 10/21/13
Liposorber® LA-15 System - H120005 [ARCHIVED] Blood Processing 10/10/13
MiniMed 530G System - P120010 [ARCHIVED] Glucose monitor/insulin delivery 09/26/13
Complete® SE Vascular Stent System - P110040 [ARCHIVED] Stent 09/19/13
GORE TAG Thoracic Endoprosthesis - P040043/S051 [ARCHIVED] Endovascular Stent Graft 09/10/13
Mobi-C® Cervical Disc Prosthesis (two-level) - P110009 [ARCHIVED] Cervical Disc Prosthesis 08/23/13
Parascript® AccuDetect® 6.1.0 - P120004 [ARCHIVED] Computer-Aided Detection (CAD) software 08/22/13
Nit-Occlud® PDA - P120009 [ARCHIVED] Occluder 08/16/13
Mobi-C® Cervical Disc Prosthesis – P110002 [ARCHIVED] Cervical Disc Prosthesis 08/07/13
therascreen® EGFR RGQ PCR Kit - P120022 [ARCHIVED] Molecular assay 07/12/13
Abbott RealTime HCV Genotype II; Abbott RealTime HCV Genotype II Control Kit; and Uracil-N-Glycosylase (UNG) - P120012 [ARCHIVED] Lab test 06/20/13
MemoryShape Breast Implants - P060028 [ARCHIVED] Breast implant 06/14/13
THxID™ -BRAF Kit for use on the ABI 7500 Fast Dx Real-Time PCR Instrument - P120014 [ARCHIVED] Molecular assay 05/29/13
Trulign Toric Posterior Chamber Intraocular Lens and Trulign Toric IOL Calculator - P030002/S027 [ARCHIVED] Intraocular Lens (IOL) 05/20/13
Selenia Dimensions 3D System - P080003/S001 [ARCHIVED] Mammography device 05/16/13
cobas® EGFR Mutation Test - P120019 [ARCHIVED] Lab Test 05/14/13
SEDASYS® Computer-Assisted Personalized Sedation System - P080009 [ARCHIVED] Sedation 05/03/13
Perclose ProGlide Suture-Mediated Closure System (ProGlide SMC) – P960043/S080 [ARCHIVED] Suture 04/15/13
TECNIS Toric 1-Piece Intraocular Lens (IOL) Models: ZCT150, ZCT225, ZCT300, ZCT400 - P980040/S039 [ARCHIVED] Intraocular Lens 04/15/13
DePuy Ceramax Ceramic Total Hip System - P070026/S004 [ARCHIVED] Hip Replacement 04/02/13
ArterX Surgical Sealant - P100030 [ARCHIVED] Surgical sealant 03/01/13
Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity) – P110013/S005 [ARCHIVED] Stent 02/22/13
Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant - P040046 [ARCHIVED] Breast implant 02/20/13
Aorfix Flexible Stent Graft System - P110032 [ARCHIVED] Stent graft 02/14/13
Argus II Retinal Prosthesis System - H110002 [ARCHIVED] Retina 02/13/13
VASCADE Vascular Closure System (VCS) - P120016 [ARCHIVED] Artery Patch 01/31/13

Page Last Updated: 01/13/2015
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