Medical Device API Endpoints

510(k) clearances

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device.

Classification

Medical device names, their associated product codes, their medical specialty areas (panels) and their classification.

Recall enforcement reports

Medical device product recall enforcement reports.

Adverse event reports

Reports of serious injuries, deaths, malfunctions, and other undesirable effects associated with the use of medical devices.

Premarket approval

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

Recalls

A recall is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Registrations and listings

The registration and listing dataset contains the location of medical device establishments and the devices manufactured at those establishments.

Unique device identifier

Global Unique Device Identification Database (GUIDID) Device Identification dataset.

COVID-19 serological testing evaluations

Serology tests detect the presence of antibodies in the blood when the body is responding to a specific infection, like COVID-19.