Vitaflo USA Renastart: Recall

<!– –> <!– Page Last Updated: 01/31/2012 –> Page Last Updated: 01/31/2012 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm289705.htm

Treanda (bendamustine HCL): Recall

<!– –> <!– Page Last Updated: 01/30/2012 –> Page Last Updated: 01/30/2012 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm289521.htm

Evaluation of Automatic Class III Designation (De Novo) Decision : K093295 added

<!– –> <!– Page Last Updated: 01/29/2012 –> Page Last Updated: 01/29/2012 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm232269.htm

Consumer Information on: M-Vu Algorithm Engine

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: M-Vu Algorithm EnginePMA Applicant: VuCOMP, [...]

Summary Information for: M-Vu Algorithm Engine

Issued January 23, 2012 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 January 27, 2012 Article source: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P100005

CDRH Ombudsman Annual Report

  U.S. Department of Health and Human Services Public Health Service Food and Drug Administration Center for Devices and Radiological Health   I. CONTACTS An inquiry may be a question, a request for clarification, or an issue that does not rise to the level of a complaint or a dispute. A complaint is typically an [...]

CDRH Ombudsman Annual Report

  U.S. Department of Health and Human Services Public Health Service Food and Drug Administration Center for Devices and Radiological Health   I. CONTACTS An inquiry may be a question, a request for clarification, or an issue that does not rise to the level of a complaint or a dispute. A complaint is typically an [...]

CDRH Ombudsman Annual Report

  U.S. Department of Health and Human Services Public Health Service Food and Drug Administration Center for Devices and Radiological Health   I. CONTACTS An inquiry may be a question, a request for clarification, or an issue that does not rise to the level of a complaint or a dispute. A complaint is typically an [...]

CDRH Ombudsman Annual Report

  U.S. Department of Health and Human Services Public Health Service Food and Drug Administration Center for Devices and Radiological Health   I. CONTACTS An inquiry may be a question, a request for clarification, or an issue that does not rise to the level of a complaint or a dispute. A complaint is typically an [...]

CDRH Ombudsman Annual Report

  U.S. Department of Health and Human Services Public Health Service Food and Drug Administration Center for Devices and Radiological Health   I. CONTACTS An inquiry may be a question, a request for clarification, or an issue that does not rise to the level of a complaint or a dispute. A complaint is typically an [...]