Objectives: 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 translated to Chinese ...
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。...
We hypothesize that knee arthroplasty devices cleared through the Food and Drug Administration (FDA) 510(k)-notification process would have a higher recall rate than the premarket approval (PMA) process. Methods The FDA database was thoroughly queried for all knee arthroplasty surgical devices from ...
Public Health Notifications (Medical Devices) - FDA Preliminary Public Health Notification*: Recall of Boston Scientific ENTERYX® Procedure Kits and ENTERYX® Injector Single Packs for Treatment of Gastroesophageal Reflux Disease (GERD) 来自 fda.gov 喜欢 0 阅读量: 29 ...
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 m...
Next, search for your drug’s manufacturer in the FDA’s Drug Recalls database. Some manufacturers provide guidance in the event of a medication recall. For example, Torrent Pharmaceuticals Limited lists all the lots and products included in its recall. It also provides contact information and in...
the HeartMate 3 is recognized as the safest mechanical heart pump in its category. However, a federal database containing over 4,500 reports suggests that this medical device may have caused or contributed to patient deaths. The recall comes years after surgeons initially obse...
–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...
The FDA stated that the recall applies to Obsidio conformable embolic distributed from May 8, 2023, to February 8, 2024, and there were 1,594 devices recalled in the United States. The product codes are available on the FDA Medical Device Recall Databasehere. ...
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...