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May 2005 Archive

The MQSA Facility Inspection: 1995 to 2005 May 28, 2005
Consumer Information on: DuraSeal Dural Sealant System May 23, 2005
Consumer Information on: Rithron-XR Coronary Stent System May 23, 2005
Obstetrics and Gynecology Devices Panel Meeting Brief Summary for May 17, 2005 May 20, 2005
Summary Information for: Boston Scientific Liberte(tm) Monorail(tm) and Over-the-Wire Coronary Stent Systems - P040016 May 20, 2005
Summary Information for: DuraSeal(tm) Sealant System - P040034 May 20, 2005
Summary Information for: Rithron-XR Coronary Stent System - P030037 May 20, 2005
Agenda, Roster, Questions and Briefing Material for the May 17, 2005 Obstetrics and Gynecology Devices Panel Meeting May 16, 2005
Class I Medical Device Recall: BioMerieux Simplastin HTF Tissue Reagent May 16, 2005
Agenda, Roster, Questions, and Briefing Material for the May 13, 2005 Anesthesiology and Respiratory Therapy Devices Panel Meeting May 13, 2005
Class I Medical Device Recalls: Laerdal Medical Corp. CM 100 HeartStart(r) Automatic External Defibrillator Adapter Cables May 13, 2005
Class I Medical Device Recalls: Welch Allyn Co., AED 20(r), Automatic External Defibrillator May 13, 2005
FDA Approves First DNA-based Test to Detect Cystic Fibrosis May 10 , 2005
MRI-Caused Injuries in Patients with Implanted Neurological Stimulators May 10 , 2005
510(k) Final Decisions - April 2005 May 5, 2005
Summary Information for: ADVIA Centaur® HBc IgM ReadyPack Reagents and ADVIA Centaur® HBc IgM Quality Control Materials - P030040 May 2, 2005
FDA Patient Safety News for May May 2, 2005
FY 2004 MDUFMA Financial Report May 2, 2005
Summary Information for: InSite(tm) Her-2/neu kit - P040030 May 2, 2005
Summary Information for: Ventana® Medical Systems' PATHWAY Anti-c-KIT (9.7) Primary Antibody - P020055 May 2, 2005