A reviewof FDA’s recall database between 2012 and 2017 demonstrates that at least fourother separate events have occurred with non-sterile aqueous based productsresulting in E. coli contamination.对2012年至 2017年间 FDA召回数据库的回顾表明,至少发生了四起其他非无菌水基药品导致大肠杆菌污染的独立事件...
medical device supervisionObjectives: To analysis of medical device recall reports and to address the safety issue of medical device. Method: Of overall reports, the recall class, product name, product class and recall reason were recorded to classify for analysis. Results: 3093 recall reports were...
不良事件是指医疗器械使用过程中可能导致死亡、重大伤害、功能失常、不良反应等的事件。制造商需要及时向FDA报告与其医疗器械相关的不良事件,以便FDA监测和评估医疗器械的安全性和有效性。 医疗器械召回(Medical Device Recall):如果存在医疗器械可能存在缺陷、不安全或不符合法规要求的情况,制造商可能会主动发起召回行动。...
Methods The FDA database was thoroughly queried for all knee arthroplasty surgical devices from January 1, 2007 through December 31, 2017. Recalled devices were analyzed by manufacturer, type of implant, recall class, manufacturer-determined reason, FDA-determined reason, quantity affected, submission ...
Defective Medical Devices Philips Agrees to Stop Selling CPAP Machines as Part of Settlement Deal Dangerous Drugs AstraZeneca Agrees to $425 Million for PPI Lawsuits[...] Dangerous Drugs GSK Settles First Zantac Cancer Lawsuit[...] Have you been affected by a drug or device listed?
For medical device manufacturers, employee training is also required to satisfy FDA and international regulatory requirements. Your training provider needs to know the medical device sector, how to create effective training for adults, and have an extensive portfolio of courses Since 1968, Oriel STAT ...
–general medical requirements that also apply to medical devices(适用于医疗器械的一般医疗要求)医疗器械注册流程: 医疗器械FDA验厂:针对美国市场,其中FDA注册是强制性要求,普通FDA注册和产品列名是针对一般低风险产品,行业内称作510K豁免产品,510K则对应针对高风险产品,也就是我们说的510k产品。FDA验厂针对部分被抽查...
Food and Drug Administration (FDA) has issued a recall of the Hologic Inc. BioZorb marker due to ... May 22, 2024 News | FDA Indica Labs Receives First FDA Clearance for HALO AP Dx Digital Pathology Platform May 14, 2024 — Indica Labs, the leading provider of digital pathology ...
The FDA's enthusiasm didn't last. In November 2019, Medtronic, citingthe ring problem, launched an "urgent medical device recall" of the pumps, which it expanded in late 2021. During an inspection at Medtronic's plant in Northridge, California, FDA officials learned the company had logged ...
The FDA today issued a notice labeling the recall of Boston Scientific Accolade pacemaker devices serious as it may cause injury or death. Last December, Boston Scientific issued a voluntary notice outlining issues with a subpopulation of Accolade, Proponent, Essentio and Altrua 2 dual-chamber stand...