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Janaury 2005 Archive

Class I Medical Device Recalls: Becton Dickinson ProbeTec ET Urine Processing Kit January 31, 2005
Consumer Information on: ADVIA Centaur(r) HBc Total ReadyPack Reagents, ADVIA Centaur(r) HBc Total Quality Control Materials January 31, 2005
Consumer Information on: ADVIA Centaur(r) HAV IgM January 27, 2005
Report to Congress: Barriers to the Availability of Medical Devices Intended for the Treatment or Diagnosis of Diseases and Conditions that Affect Children January 24, 2005
Consumer Information on: Reflection(r) Ceramic Acetabular System January 24, 2005
Summary Information for: OSTEOSPACE - P010058 January 21, 2005
Summary Information for: ADVIA Centaur(r) Anti-HBs ReadyPack Reagents and ADVIA Centaur(r) Anti-HBs ReadyPack Calibrators - P030029 January 21, 2005
Summary Information for: ARTISAN(r) (Model 206 and 204) Phakic Intraocular Lens (PIOL) Verisyse(tm) (VRSM5US and VRSM6US) Phakic Intraocular Lens (PIOL) - P030028 January 21, 2005
Summary Information for: Reflection(r) Ceramic Acetabular System - P030022 January 21, 2005
Summary Information for: Cervical-Stim(r) Model 505L Cervical Fusion System - P030034 January 21, 2005
Brief Summary from the January 13, 2005 Circulatory System Devices Panel Meeting January 18, 2005
Presentation: Best Practices for Effective and Productive Premarket Meetings with CDRH January 18, 2005
Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and FDA Staff January 14, 2005
Transcript from the 2nd Annual MDUFMA Stakeholders Meeting, Thursday, November 18, 2004 January 14, 2005
FDA Responds to NRPB Report on Mobile Phones and Health January 13, 2005
PMA Final Decisions for December 2004 January 13, 2005
The Effect of Reducing Inspection Frequency: A Study Authorized by the Mammography Quality Standards Reauthorization Act of 1998 January 12, 2005
Consumer Information on: InSite(tm) Her-2/neu Kit January 11, 2005
Consumer Information on: URYX(r) Urethral Bulking Agent January 11, 2005
Consumer Information on: Kodak Mammography CAD ENGINE - P030007 January 6, 2005
Consumer Information on: Nuflexxa(tm) (1% Sodium Hyaluronate) - P010029 January 6, 2005
510(k)s Final Decisions Rendered for December 2004 January 5, 2005
Consumer Information on: Endologix PowerLink(r) System - P040002 January 3 , 2005
ADA / FDA Guide to Patient Selection for Dental Radiographs January 3 , 2005
Class I Medical Device Recalls: Unomedical Airway Adapter January 3 , 2005