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Summary Information for: Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM
Issued October 26, 2011 Approval Order Summary Labeling Other Consumer Information This document is in a Portable Document Format (PDF). Acrobat Reader is required to read this document. Updated November 4, 2011
Class I Medical Device Recall: CareFusion EnVe Ventilators
Recall Class: Class I Date Recall Initiated: 9/12/2011 Product(s): CareFusion EnVe Ventilator, model 19250-001. Range of Manufacturing Dates: The affected products were manufactured between December 2010 and May 2011. Use: The CareFusion EnVe Ventilator is a portable ventilator used to provide breathing assistance to pediatric and adult patients in hospital and medical transport settings. Recalling…
Summary Information for: Assurant® Cobalt Iliac Balloon-Expandable Stent System
Issued October 26, 2011 Approval Order Summary Labeling Other Consumer Information This document is in a Portable Document Format (PDF). Acrobat Reader is required to read this document. Updated November 4, 2011
FDA Drug Safety Communication: Reminder to healthcare providers and patients to enroll in the Avandia-Rosiglitazone Medicines Access Program
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Consumer Information on: Assurant® Cobalt Iliac Balloon-Expandable Stent System
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Consumer Information on: APTIMA® HPV Assay
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Summary Information for: APTIMA HPV Assay
Issued October 28, 2011 Approval Order Summary Labeling Other Consumer Information This document is in a Portable Document Format (PDF). Acrobat Reader is required to read this document. Updated November 4, 2011
CareFusion EnVe Ventilators: Class I Recall
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FDA Drug Safety Communication: UPDATE on Tumor Necrosis Factor (TNF) blockers and risk for pediatric malignancy
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