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May 2004 Archive

Mammography Facility Adverse Event and Action Report 2003 May 27, 2004
Medical Device Recalls - Class 1 Recall: Arjo MINSTREL Patient Lifts May 27, 2004
Summary Information for: Oculaid(tm) Capsular Tension Ring (Model 275 10/12 mm and Model 276 11/13 mm) and Stableyes(tm) Capsular Tension Ring (Model 275 10/12 mm and Model 276 11/13 mm) - P030023 May 26, 2004
Summary Information for: INFUSE(r) Bone Graft - P000054 May 26, 2004
Summary Information for: St. Jude Frontier(tm) Biventricular Cardiac Pacing System including the Frontier(tm) Model 5508 and 5508L Pulse Generators, the Aescula(tm) LV Model 1055K Lead and the Model 3307 v4.4.2m programmer software for use with the Model 3500/3510 Programmer - P030035 May 26, 2004
FDA & You, Issue #3 - Spring/Summer 2004 May 25, 2004
Medical Device Recalls - Class 1 Recall: Paradigm Quick-set Plus Insulin Administration Set May 20, 2004
Consumer Information on: INFUSE(r) Bone Graft May 18, 2004
Medical Device Recalls - Class 1 Recall: Biliary Stents Instructions for Use May 10, 2004
Consumer Information on: Hylaform May 10, 2004
FDA Public Health Web Notification: Counterfeit Polypropylene Mesh - Updated May 7, 2004
FDA Public Health Web Notification: Complications Related to the Use of Bone Cement and Bone Void Fillers in Treating Compression Fractures of the Spine - Updated May 7, 2004
Consumer Information on: Oxford(tm) Meniscal Unicompartmental Knee System May 7, 2004
FDA Talk Paper: FDA Proposes Rule on "Combination" Products May 6, 2004
Special note of interest: A new synthesis of studies of how poor literacy skills affect the use of health care services and health outcomes, "Literacy and Health Outcomes," is now available on the website of HHS' Agency for Healthcare Research and Quality May 6, 2004
510(k) Final Decisions Rendered for April 2004 May 5, 2004
Summary Information for: Hylaform (hylan B gel) - P030032 May 5, 2004
Summary Information for: Oxford(tm) Meniscal Unicompartmental Knee System - P010014 May 5, 2004
Summary Information for: Abbott AxSYM(r) Anti-HCV - P970027 May 5, 2004
Announcement of Upcoming Meeting of the Circulatory Devices Panel - June 8, 2004 May 4, 2004
Consumer Information on: CellSearch(tm) Epithelial Cell Kit /CellSpotter(tm) Analyzer May 4, 2004
Consumer Information on: Vitros Immunodiagnostic Products Anti-HBc Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc Calibrator May 4, 2004
Consumer Information on: Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc IgM Calibrator May 4, 2004
Consumer Information on: Orthovisc(r) High Molecular Weight Hyaluronan May 4, 2004
FDA's Office of Crisis Management Emergency Response Plan Summaries May 4, 2004