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Medical Devices

2006 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 2006

2006 Device Approvals

Device NameCategoryDate
Radiesse - P050037 [ARCHIVED] Wrinkle Filler 12/22/06
Radiesse - P050052 [ARCHIVED] Wrinkle Filler 12/22/06
Cosmetic Tissue Augmentation Product - P050033 [ARCHIVED] Wrinkle Filler 12/20/06
Olympic Cool-Cap ®- P040025 [ARCHIVED] Cooling Unit 12/20/06
The Spanner™ Temporary Prostatic Stent - P060010 [ARCHIVED] Stent 12/14/06
Allergan Inamed® Silicone-Filled Breast Implants - P020056 [ARCHIVED] Breast Implant 11/17/06
Mentor MemoryGel™ Silicone Gel-Filled Breast Implants - P030053 [ARCHIVED] Breast Implant 11/17/06
Paragon Z CRT® (tisilfocon A) Rigid Gas Permeable Contact Lenses for Corneal Refractive Therapy - P050031 [ARCHIVED] Contact Lens 11/16/06
Macroplastique ® Implants - P040050 [ARCHIVED] Urinary Bulking Agent 10/30/06
ArteFill® - P020012 [ARCHIVED] Wrinkle Filler 10/27/06
NexStent® - P050025 [ARCHIVED] Stent 10/27/06
Arista™ AH Absorbable Hemostat - P050038 [ARCHIVED] Blood Clotting Aid 09/26/06
Cordis PRECISE™ OTW Nitinol Stent System - P030047 [ARCHIVED] Stent 09/22/06
INTROL™ CF Panel I Control - K060070 [ARCHIVED] Cystic Fibrosis Test 09/18/06
AxSYM CORE™ 2.0 - P060012 [ARCHIVED] Hepatitis Test 09/08/06
ARCHITECT® HBsAg Assay - P060007 [ARCHIVED] Hepatitis Test 09/07/06
AbioCor® Implantable Replacement Heart - H040006 [ARCHIVED] Artificial Heart 09/05/06
AxSYM CORE-M ™ 2.0 Controls - P060009 [ARCHIVED] Hepatitis Test 08/25/06
MONOLISA™ Anti-HBs and MONOLISA™ Anti-HBs Calibrator Kit - P050048 [ARCHIVED] Hepatitis Test 08/25/06
PRODISC®-L Total Disc Replacement - P050010 [ARCHIVED] Spinal Disc 08/14/06
Carl Zeiss Meditec MEL 80 Excimer Laser System - P060004 [ARCHIVED] LASIK 08/11/06
Gore HELEX® Septal Occluder - P050006 [ARCHIVED] Septal Occluder 08/11/06
BIOTRONIK’s Kronos LV-T and Tupos LV/ATx Implantable Cardioverter Defibrillator Systems with Cardiac Resynchronization Therapy - P050023 [ARCHIVED] Defibrillator 08/10/06
AxSYM® AUSAB® Reagent Kit, Calibrator and Controls - P060003 [ARCHIVED] Hepatitis Test 08/07/06
Adept® Adhesion Reduction Solution (4 percent Icodextrin) - P050011 [ARCHIVED] Adhesion Prevention 07/28/06
Fuji Computed Radiography Mammography Suite (FCRMS) - P050014 [ARCHIVED] Mammography 07/10/06
Trilogy AB Acetabular System - P040048 [ARCHIVED] Hip Prosthesis 06/28/06
Zilver Vascular Stent - P050017 [ARCHIVED] Stent 06/26/06
Vitagel™ Surgical Hemostat - P050044 [ARCHIVED] Hemostat 06/16/06
ARCHTECT® Anti-HCV - P050042 [ARCHIVED] Hepatitis Test 06/07/06
Juvéderm Gel Implants - P050047 [ARCHIVED] Wrinkle Filler 06/02/06
ARCHITECT® AUSAB® Reagent Kit - P050051 [ARCHIVED] Hepatitis Test 06/01/06
AxSYM® HBsAg Assay - P050049 [ARCHIVED] Hepatitis Test 06/01/06
Stelkast Supass™ Acetabular System - P040051 [ARCHIVED] Hip Prosthesis 05/12/06
Birmingham Hip Resurfacing (BHR) System - P040033 [ARCHIVED] Hip Prosthesis 05/09/06
PhiCal™ Fecal Calprotectin Immunoassay - K050007 [ARCHIVED] Fecal Test 04/26/06
Karl Storz Rigid TTTS Fetoscopy Instrument Set - H040005 [ARCHIVED] Fetoscope Instrument 03/31/06
DexCom™ STS™ Continuous Glucose Monitoring System - P050012 [ARCHIVED] Glucose Monitor 03/24/06
LUMA™ Cervical Imaging System - P040028 [ARCHIVED] Cervical Imaging System 03/16/06
MonoPrep Pap Test - P040052 [ARCHIVED] Cervical Cancer Test 03/03/06

Page Last Updated: 09/05/2013
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