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Medical Devices

2010 Device Approvals

The products listed in this section include some of the newest medical technology from the year 2010. 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 2010

2010 Device Approvals

Device NameCategoryDate
Bard LifeStent and LifeStent XL Vascular Stent - P070014/S010 [ARCHIVED] Stent 12/23/10
DePuy Orthopaedics Ceramax Ceramic Total Hip System - P070026 [ARCHIVED] Hip Replacement 12/23/10
Arctic Front® Cardiac CryoAblation Catheter - P100010 [ARCHIVED] Catheter 12/17/10
Endurant Stent Graft System - P100021 [ARCHIVED] Stent 12/16/10
KODAK DirectView CR Mammography System - P080018 [ARCHIVED] Mammography 11/03/10
Dako HER2 FISH pharmDx™ - P040005/S005 [ARCHIVED] Cancer Test 10/20/10
Dako HercepTest™ - P980018/S010 [ARCHIVED] Cancer Test 10/20/10
EC-3 Posterior Chamber Intraocular Lenses (IOLs), Models EC-3 and EC-3 Precision Aspheric Lens (PAL) - P100016 [ARCHIVED] Intraocular Lens 10/19/10
Boston Scientific Cardiac Resynchronization Therapy Defibrillators - P010012/S230 [ARCHIVED] Defibrillator 09/16/10
Abbott RealTime HBV Assay - P080026 [ARCHIVED] HBV test 08/13/10
Implantable Miniature Telescope™ - P050034 [ARCHIVED] Ophthalmic 07/01/10
OraQuick HCV Rapid Antibody Test - P080027 [ARCHIVED] Antibody Test 06/25/10
Photodynamic Diagnostic D-Light C (PDD) System - P050027 [ARCHIVED] Cystoscopy 05/28/10
Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV on the MODULAR ANALYTICS E170 Immunoassay Analyzer - P090009 [ARCHIVED] Immunoassay Analyzer 04/29/10
Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV on the cobas e 601 Immunoassay Analyzer - P090008 [ARCHIVED] Immunoassay Analyzer 04/29/10
Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV on the cobas e 411 Immunoassay Analyzer - P090007 [ARCHIVED] Immunoassay Analyzer 04/29/10
Asthmatx, Inc. Alair Bronchial Thermoplasty System - P080032 [ARCHIVED] Thermoplasty System 04/27/10
Softec HD Aspheric Posterior Chamber Intraocular Lens - P090022 [ARCHIVED] Intraocular Lens 04/12/10
Quick-Close® Vascular Suturing System - P080029 [ARCHIVED] Sutures 04/08/10
STERIS System 1E (SS1E) Liquid Chemical Sterilant - K090036 [ARCHIVED] Sterilant 04/05/10
Esteem® Implantable Hearing System - P090018 [ARCHIVED] Hearing Implant 03/17/10
Medtronic Vascular Complete® SE Vascular Stent System - P090006 [ARCHIVED] Stent 03/17/10
Express® LD Iliac Premounted Stent System - P090003 [ARCHIVED] Stent 03/05/10
Ethicon™ OMNEX™ Surgical Sealant - P060029 [ARCHIVED] Surgical Sealant 03/03/10
Medtronic Melody® Transcatheter Pulmonary Valve - H080002 [ARCHIVED] Heart Valve 01/25/10
Thoratec HeartMate II LVAS - P060040/S005 [ARCHIVED] LVAS 01/20/10
ProGEL™ Pleural Air Leak Sealant - P010047 [ARCHIVED] Surgical Sealant 01/14/10

Page Last Updated: 09/06/2013
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