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November 2001 Archive

Consumer Information on: Focus® Night and Day Soft Contact Lens
November 30, 2001
Consumer Information on: OP-1 Implant
November 30, 2001
Briefing Material for the 11/30/01 Ophthalmic Devices Panel Meeting
November 29, 2001
Summary Information for: PureVision (tm)(balafilcon A) Visibility Tinted Contact Lens
November 29, 2001
Summary Information for: Ascension MCP
November 29, 2001
Consumer Information on: IMMULITE AFP and IMMULITE 2000 AFP
November 29, 2001
Consumer Information on: SenoScan® Full Field Digital Mammography System
November 29, 2001
Consumer Information on: Diomed 630 PDT Laser Model T2USA
November 29, 2001
United States Agents for Devices
November 29, 2001
Minutes from the Thirteenth US/EC MRA Medical Device Annex Stakeholders Teleconference (November 7, 2001)
November 29, 2001
Minutes from the Thirteenth US/EC MRA Medical Device Annex Stakeholders Teleconference (November 7, 2001)
November 26, 2001
Summary Information for: VISX STAR Excimer Laser System Models S2 and S3
November 21, 2001
Summary Information for: GYNECARE INTERGEL Adhesion Prevention Solution
November 21, 2001
FDA Approves New Anti-Adhesion Treatment for Gynecologic Surgery
November 20, 2001
Summary Information for: Model 3100B High-Frequency Oscillatory Ventilator
November 20, 2001
Science at Work in CDRH: A Report on the Role of Science in the Regulatory Process; Final Report
November 19, 2001
Summary Information for GALILEO Intravascular Radiotherapy System
November 14, 2001
Summary Information for Elecsys® HBsAg Immunoassay, Elecsys® HBsAg ConfirmatoryTest, and Elecsys® PreciControl HBsAg
November 14, 2001
Summary Information for SensoScan® Full Field Digital Mammography System
November 14, 2001
User Facility Reporting Bulletin - Fall 2001
November 9, 2001
Presentation: Reuse of Single Use Devices: FDA's Regulatory Requirements for Third Party and Hospital Reprocessors (11/5/01)
November 9, 2001
FDA Investigating Role of Baxter's Recalled Dialyzers in Kidney Dialysis Patient Deaths
November 7, 2001
Premarket Approval Decisions (PMA) for October 2001
November 7, 2001
Clinical Chemistry and Clinical Toxicology Devices Panel Meeting Summary for October 29, 2001
November 6, 2001
510(k)Decisions Rendered for October 2001
November 5, 2001
Medical Device Recalls
November 5, 2001
FDA Public Health Notification: Reducing Radiation Risk from Computed Tomography for Pediatric and Small Adult Patients
November 5, 2001
Buying Diagnostic Tests From the Internet
November 1, 2001