To access this database, click this link:Redacted FOIA 510k Database. To limit your search to only 510k submissions that are available as a redacted full 510k, click on the box for “Redacted FOIA 510k.” If you want to learn more about how to make the most of this new resource, plea...
None of DePuy Synthes, Inc., Medical Device Business Services, Inc., nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. * Comprising the surg...
2007年三年中收到超过1000例来自9个厂商关于在治疗POP及压力性尿失禁手术中放置网片后出现相关并发症的不良事件报告,美国FDA为此2008年10月专门发布安全信息通告,以期引起全球妇科泌尿医生的重视。此后不良事件数量持续攀升,FDA器械不良反应注册数据库(Manufacturer and User Facility Device Experience database)调查显示2008...
US FDA Registration is mandated for every company by the United States Food and Drug Administration Department, which is responsible for monitoring