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The Annual MQSA Inspection: What Facilities Can Do To Help
The annual inspection under the Mammography Quality Standards Act (MQSA) is the time when an MQSA certified inspector assesses a facility’s compliance with MQSA quality standards. To reduce the amount of time away from the facility’s job of patient care, the scope of the standard inspection questions is designed to check areas that FDA believes…
XtraHRD Natural Male Enhancement Capsules by Organic Herbal Supply, Inc.: Recall
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Meeting materials posted for February 23, 2017 Circulatory System Devices Panel of the Medical Devices Advisory Committee
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Comprehensive Reverse Shoulder by Zimmer Biomet: Class I Recall
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HCG (Human Chorionic Gonadotropin) Freeze Dried Vials by Synergy Rx: Recall
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Class I Medical Device Recall: Zimmer Biomet Recalls Comprehensive Reverse Shoulder due to a High Fracture Rate
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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150038 and DEN150057 added)
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Class I Medical Device Recall: Physio-Control Recalls LIFEPAK15 Monitor/Defibrillator Due to Failure of Electrical Shock Delivery
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product The LIFEPAK 15 Monitor/Defibrillator (LP15) Serial Numbers: See full list below Distribution Dates: September 13, 2014, to July 4, 2016 Manufacturing Dates: September 3, 2014 to June…
La FDA advierte acerca de reacciones alérgicas poco comunes pero graves del antiséptico tópico con gluconato de clorhexidina
La Administración de Alimentos y Medicamentos de Estados Unidos (FDA, por sus siglas en inglés) advierte que se han reportado reacciones alérgicas poco comunes pero graves con los ampliamente utilizados productos antisépticos tópicos que contienen gluconato de clorhexidina. Si bien son poco comunes, el número de reportes de reacciones alérgicas graves por estos productos ha…