Background As part of the Mammography Quality Standards Act (MQSA), Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and that it should include information that is useful in evaluating the performance of mammography facilities nationwide. In…
Class I Medical Device Recall: Medtronic Respiratory and Monitoring Solutions Recalls Battery Pack Used on Patient Monitors Due to Potential Fire Risk
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24 Hour Summary posted for May 24, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee
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FDA-Industry MDUFA IV Reauthorization Meeting, April 27, 2016
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Class I Medical Device Recall: Hummingbird Med Devices Inc. Recalls Hummi Micro-Draw Blood Transfer Device Due to Potential for Parts to Disconnect
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Mammography Facility Adverse Event and Action Report
Background As part of the Mammography Quality Standards Act (MQSA), Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and that it should include information that is useful in evaluating the performance of mammography facilities nationwide. In…
Webinar – Artificial Pancreas: A Dialogue between the FDA and the Diabetes Community
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April 2016 PMA Approvals
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Summary Information for: Epi proColon
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Meeting Materials posted for May 24, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee
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