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Medical Devices

2005 Device Approvals

The products listed below contain information about what medical uses the device is 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 Approved by FDA in 2005

Device NameCategoryDate
Visian ICL™ - P030016 [ARCHIVED] Intraocular Lens (IOL) 12/22/05
StarClose™ Vascular Closure System - P050007 [ARCHIVED] Vascular Sealant 12/21/05
Ceralas I Laser and Ceralink Slit Lamp Adapter - P050021 [ARCHIVED] Laser 12/20/05
VISTAKON® (senofilcon A) Contact Lens - P040045 [ARCHIVED] Contact Lens 12/20/05
C2a – Taper™ Acetabular System - P050009 [ARCHIVED] Hip Prostheses 12/16/05
X STOP® Interspinous Process Decompression System (XSTOP) - P040001 [ARCHIVED] Spinal Implant 11/21/05
GEM 21S (Growth-factor Enhanced Matrix) - P040013 [ARCHIVED] Dental Bone Filler 11/18/05
IBI Therapy™ Dual 8™ Ablation Catheter and IBI 1500T6 (USA) Cardiac Ablation Generator - P040042 [ARCHIVED] Ablation Catheter 11/18/05
Coaptite® - P040047 [ARCHIVED] Urinary Bulking Agent 11/10/05
STAN® S31 Fetal Heart Monitor - P020001 [ARCHIVED] Heart Monitor 11/01/05
Total Temporomandibular Joint Replacement System - P020016 [ARCHIVED] Jaw Prostheses 09/21/05
ACRYSOF® Single-Piece Posterior Chamber Intraocular Lenses With Toric Optic, Models SA60T3, SA60T4 and SA60T5 - P930014/S015 [ARCHIVED] Intraocular Lens (IOL) 09/14/05
Xact® Carotid Stent System - P040038 [ARCHIVED] Stent 09/06/05
Matrix VSG™ System - P040044 [ARCHIVED] Vascular Sealant 08/17/05
Orbasone Pain Relief System - P040039 [ARCHIVED] Shock Wave Therapy 08/10/05
SJM Biocor™ and Biocor™ Supra Valves - P040021 [ARCHIVED] Heart Valve 08/05/05
SelectSecure™ Lead Model 3830 - P030036 [ARCHIVED] Pacemaker Lead 08/03/05
Wingspan™ Stent System with Gateway™ PTA Balloon Catheter - H50001 [ARCHIVED] Stent 08/03/05
Onyx® Liquid Embolic System (LES) - P030004 [ARCHIVED] Embolizing Device 07/21/05
VNS Therapy System - P970003s050 [ARCHIVED] Vagus Nerve Stimulator 07/15/05
DakoCytomation c-Kit pharmDx™ - P040011 [ARCHIVED] Gastrointestinal Tumor Test 06/27/05
GORE VIABAHN™ Endoprosthesis - P040037 [ARCHIVED] Stent 06/14/05
ADVIA Centaur® HBsAg ReadyPack Reagents, ADVIA Centaur® HBsAg Confirmatory ReadyPack Reagents, and ADVIA Centaur® HBsAg Quality Control Material - P030049 [ARCHIVED] Hepatitis Test 05/31/05
Wako LBA AFP-L3 - K041847 [ARCHIVED] Liver Cancer Test 05/19/05
Tag-It™ Cystic Fibrosis Kit - K043011 [ARCHIVED] Cystic Fibrosis Test 05/09/05
Duraloc® Option Ceramic Hip System - P040023 [ARCHIVED] Hip Prostheses 05/03/05
DakoCytomation Her2 FISH pharmDx™ Kit - p040005 [ARCHIVED] Breast Cancer Test 05/03/06
Rithron-XR Coronary Stent System - P030037 [ARCHIVED] Stent 04/29/05
Decapinol Oral Rinse - K041482 [ARCHIVED] Gingivitis Rinse 04/18/05
PAXgene™ Blood RNA System - K042613 [ARCHIVED] Genetic Test 04/18/05
Boston Scientific Liberte™ Monorail™ and Over-the-Wire Coronary Stent Systems - P040016 [ARCHIVED] Stent 04/12/05
DuraSeal Dural Sealant System - P040034 [ARCHIVED] Dural Sealant 04/07/05
OrthospecTM Extracorporeal Shock Wave Therapy - P040026 [ARCHIVED] Shock Wave Therapy 04/01/05
CoAxia NeuroFlo™ Catheter - H030005 [ARCHIVED] Catheter 03/30/05
Restylane™ Injectable Gel - P040024 [ARCHIVED] Wrinkle Filler 03/25/06
GORE TAG Thoracic Endoprosthesis - P040043 [ARCHIVED] Vascular Graft 03/23/05
AcrySof® ReSTOR Apodized Diffractive Posterior Chamber Intraocular Lens (IOL) - P040020 [ARCHIVED] Intraocular Lens (IOL) 03/21/05
ADVIA Centaur® HAV Total Assay - P040017 [ARCHIVED] Hepatitis Test 03/07/05
UroVysion™ Bladder Cancer - P030052 [ARCHIVED] Bladder Cancer Test 01/24/05
IBI Therapy™ Cardiac Ablation System - P040014 [ARCHIVED] Ablation Catheter 01/14/05

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