Items added to the FDA's Center for Devices and Radiological Health website within the last month. http://www.fda.gov/cdrh/newpg.html en-us Sat, 21 Nov 2009 02:28:18 GMT webo@cdrh.fda.gov http://www.fda.gov/cdrh/images/homepg/c-d-r-h.gif http://www.fda.gov/cdrh/ Device: Cardiac Science Powerheart and CardioVive Automated External Defibrillator(AED) G3 Series manufactured between August 2003 and August 2009. These devices are used for emergency treatment of victims with symptoms of sudden cardiac arrest who are... Thu, 19 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm191426.htm Cautions healthcare facilities about the risks to patients if flexible endoscopes and their accessories are not processed properly. Thu, 19 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm190273.htm Labeling, Approval Order, and Summary of Safety and Effectiveness for CONSERVE® Plus Total Resurfacing Hip System (P030042). Wed, 18 Nov 2009 05:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P030042 The CONSERVE® Plus Total Resurfacing Hip System is a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The CONSERVE® Plus Total Resurfacing Hip System is called a resurfacing prosthesis because... Wed, 18 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm191091.htm The committee will review and discuss recent information, including recent literature regarding the possible risks to the general public from intentional exposure to ultraviolet radiation (UV) from use of tanning lamps. Tue, 17 Nov 2009 05:00:00 GMT http://edocket.access.gpo.gov/2009/E9-27491.htm The committee will discuss guidance documents issued since the last meeting. The committee will also receive updates on: Interventional mammography accreditation programs, recently approved alternative standards, facility inspection findings, the status.. Tue, 17 Nov 2009 05:00:00 GMT http://edocket.access.gpo.gov/2009/E9-27492.htm These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for October 2009. Tue, 17 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm190924.htm This is to alert you to deaths and serious complications, especially bleeding and infection, associated with the use of Negative Pressure Wound Therapy (NPWT) systems, and to provide recommendations to reduce the risk. Although rare, these complications.. Mon, 16 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm190658.htm The FDA is announcing the reopening until November 15, 2010 of a public docket to receive information and comments on laser-assisted in situ keratomileusis (LASIK) devices. Fri, 13 Nov 2009 05:00:00 GMT http://edocket.access.gpo.gov/2009/E9-27222.htm Loss of device height may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for a reoperation or an operation to modify the implanted device. Thu, 12 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm190300.htm The device blocks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures. Mon, 09 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm189615.htm The Food and Drug Administration?s eSubmitter tool is part of an electronic submissions program that originated in the Center for Devices and Radiological Health (CDRH). The eSubmitter program is the result of two successful pilot programs at CDRH named.. Mon, 09 Nov 2009 05:00:00 GMT http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm FDA is issuing this guidance to inform industry and agency staff of its recommendations for the type of information and data FDA believes needs to be included in an Emergency Use Authorization Request (EUA) for in vitro diagnostic (IVD) devices intended.. Fri, 06 Nov 2009 05:00:00 GMT http://edocket.access.gpo.gov/2009/E9-26737.htm Reason for Recall: Laboratories are unable to recover patient samples above 200mg/dL that results in inaccurate glucose values above this range. Fri, 06 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm189467.htm Thu, 05 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ucm189265.htm The October 2008 Memorandum of Understanding between the FDA and WebMD will continue as written for five years from the date of the signature by the latter Party to sign the October 2009 Addendum to the Memorandum between the FDA and WebMD, L.L.C., whereu Thu, 05 Nov 2009 05:00:00 GMT http://edocket.access.gpo.gov/2009/E9-26674.htm FDA is investigating energy levels in external biphasic defibrillators with shocks = 200 J. We have received reports of 14 events since 2006 in which a 200 J biphasic defibrillator was ineffective in providing defibrillation/cardioversion therapy to a... Thu, 05 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm189259.htm This document provides guidance on the type of information and data that FDA recommends you include in an Emergency Use Authorization (EUA) request for in vitro diagnostic (IVD) devices intended for use in diagnosing 2009 H1N1 Influenza virus infections.. Thu, 05 Nov 2009 05:00:00 GMT The VIDAS fPSA rt Assay is a lab tests, used along with digital rectal examination, to help diagnose prostate cancer in men age 50 years and older. Thu, 05 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm189301.htm Labeling, Approval Order, and Summary of Safety and Effectiveness for VIDAS free PSA rt (fPSA) Assay (P080008). Thu, 05 Nov 2009 05:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P080008 Reason for Recall: The manufacturer of the pediatric tracheal tubes used in these kits recalled them because they were manufactured with an internal diameter smaller than indicated on the label, which could result in an inability to remove secretions... Wed, 04 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm188972.htm FDA wants to remind you that cybersecurity for medical devices and their associated communication networks is a shared responsibility between medical device manufacturers and medical device user facilities. Wed, 04 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm189111.htm Reason for Recall: A potential malfunction may cause serious injury or death. Tue, 03 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm188795.htm On December 18, 2009, the committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by Envoy Medical Corporation, for the Esteem Totally Implantable Hearing System. Mon, 02 Nov 2009 05:00:00 GMT http://edocket.access.gpo.gov/2009/E9-26260.htm On December 11, 2009, the committee will discuss and make recommendations on the study designs and endpoints of clinical investigations intended to support approval or clearance of devices indicated for the primary treatment of localized prostate cancer. Mon, 02 Nov 2009 05:00:00 GMT http://edocket.access.gpo.gov/2009/E9-26259.htm The postponement of the November 20, 2009 meeting is due to a scheduling conflict. A future meeting date will be announced in the Federal Register. Mon, 02 Nov 2009 05:00:00 GMT http://edocket.access.gpo.gov/2009/E9-26261.htm The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Thu, 22 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-25395.htm The committee will discuss and make recommendations regarding the agency's regulatory strategy for Full Field Digital Mammography (FFDM) Devices. Thu, 22 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-25406.htm