Recall Class: Class I Date Recall Initiated: October 26, 2011 Product: OSI Modular Table Systems (including Modular Bases, Jackson Spinal, Imaging, Lateral, Orthopedic Tops) Manufacturing From: January 1992 – June 2011 Distribution From: January 1992 – June 2011 The affected models and lot numbers can be found below: Use: For patient positioning during a diverse…
Trilipix (fenofibric acid): Drug Safety Communication
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Mizuho OSI Modular Table Systems: Class I Recall
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Needles and Other Sharps (Safe Disposal Outside of Health Care Settings)
This webpage gives tips for safely disposing (getting rid of) needles and other sharp devices that are used outside of health care settings. Patients and caregivers should keep these tips in mind when at home, at work, and while traveling. What are Sharps? Importance of Safe Sharps Disposal What to Do If You Are Accidently…
Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled, “Bridging the IDEAL and TPLC Approaches for Evidence Development for Surgical Medical Devices and Procedures; Public Workshopâ€. The purpose of the public workshop is to provide a forum for discussion among FDA, governmental agencies, academia, physicians and various stakeholders to f urther refine…
Minutes From Negotiation Meeting on MDUFA III Reauthorization, October 21, 2011
FDA – Industry MDUFA III Reauthorization MeetingOctober 21, 2011, 10:20 am – 5:00 pmFDA White Oak Building 1, Silver Spring, MDRoom 2102 Purpose To discuss MDUFA III reauthorization. Participants Meeting Start Time: 10:20 am FDA provided a response and counter-proposal to the proposal offered by Industry1 on October 6, 2011. Product Development Goals Industry’s October…
Draft Guidance for Industry and Food and Drug Administration Staff
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Summary Information for: XIENCE PRIME and XIENCE PRIME LL Everolimus-Eluting Coronary Stent System
Issued November 1, 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
Consumer Information on: XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System
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Global Harmonization Task Force: New International Medical Device Regulators' Forum Statement and Announcement of First Meeting
        1992 - About GHTF Steering Committee Study Groups GHTF Documents Meetings Training Liaison Bodies Newsroom On Oct 6-7, 2011, representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and United States, as well as the World Health Organisation (WHO), met in Ottawa to address the establishment and operation of…