OpenFDA Device API

OpenFDA Device API是美国食品药品监督管理局(FDA)提供的医疗设备相关数据开放API接口。该数据库包含医疗设备的510(k)分类、不良事件报告、召回信息、上市前审批、注册与 listing、唯一设备标识符以及COVID-19血清学测试评估等数据。作为美国卫生与公共服务部下属机构，FDA通过此平台开放医疗设备监管数据，供公众和研究人员使用。OpenFDA Device API is an open application programming interface (API) for medical device-related data provided by the U.S. Food and Drug Administration (FDA). This database covers multiple types of medical device data including 510(k) classifications, adverse event reports, recall information, premarket approvals, registration and listing records, Unique Device Identifiers (UDI), and COVID-19 serological test evaluations. As an agency under the U.S. Department of Health and Human Services, the FDA opens this platform to make medical device regulatory data available to the public and researchers.