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Video: LASIK Surgery and its Risks
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Class I Medical Device Recall: CooperVision Avaira (enfilcon A) Sphere Soft Contact Lenses
Recall Class: Class I Date Recall Initiated: November 15, 2011 Product(s): Avaira (enfilcon A) Sphere Soft Contact Lenses Go to the CooperVision recall web page at www.coopervision.com/international-recall, and enter the package lot number to determine whether the lenses have been recalled or contact the toll-free consumer hotline at 1-855-526-6737. These lenses were manufactured from February…
CooperVision Avaira (enfilcon A) Sphere Soft Contact Lens: Class 1 Recall
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Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication – Safety Review of Post
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FDA Drug Safety Communication: Modified Risk Evaluation and Mitigation Strategies (REMS) for Nplate (romiplostim) and Promacta (eltrombopag)
Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary  Safety Announcement [12-6-2011] The U.S. Food and Drug Administration (FDA) has approved modifications to the Risk Evaluation and Mitigation Strategies (REMS) for platelet-booster drugs Nplate (romiplostim) injection and Promacta (eltrombopag) tablets. The modifications include the removal of certain elements of the REMS, including the…
Transcript for October 13, 2011 Circulatory System Devices Panel of the Medical Devices Advisory Committee
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Class I Medical Device Recall: Draeger Medical Inc., Infinity Acute Care System Monitoring Solution (M540)
Recall Class: Class I Date Recall Initiated: October 18, 2011 Product: Infinity Acute Care System Monitoring Solution (M540), Catalog number MS25510 All serial numbers are affected by this recall. This product was manufactured from March 1, 2011 through September 30, 2011 and distributed only to the Rush University Medical Center (Chicago, Illinois) from July 1, 2011…
Meeting Materials for December 7-8, 2011 Circulatory System Devices Panel of the Medical Devices Advisory Committee
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Notice of Cancellation of Meeting: December 14, 2011 Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-P-0176] SEDASYS Computer-Assisted Personalized Sedation System; Ethicon Endo-Surgery, Incorporated’s Petition for Review of the Food and Drug Administration’s Denial of Premarket Approval; Notice of Cancellation of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Medical Devices Dispute…