Open.fda.gov

Registration and Listing

WEBOwners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the …

Actived: 6 days ago

URL: https://open.fda.gov/data/registrationlisting/

Device Registrations & Listings Overview

WEBThe openFDA registration and listing API contains the location of medical device establishments and the devices manufactured at those establishments. Owners or …

Category: Medical Go Health

Substance Data Overview

WEBFDA is a key source for substance information that is precise to the molecular level for use internally and externally (where appropriate). FDA’s Health Informatics program defines …

Category: Health Go Health

Drug Enforcement Overview

WEBThe openFDA drug enforcement reports API returns data from the FDA Recall Enterprise System (RES), a database that contains information on recall event information …

Category: Health Go Health

Structured Product Labeling

WEBThe openFDA drug product labeling API returns data from these submissions for both prescription and over-the-counter (OTC) drugs. The labeling is broken into sections, …

Category: Health Go Health

Adverse Food Event Overview

WEBThe openFDA food, dietary supplements, and cosmetic adverse event API returns data from the Center for Food Safety and Applied Nutrition Adverse Event Reporting System …

Category: Supplements, Nutrition, Food Go Health

Device 510(k) Overview

WEBA 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 …

Category: Health Go Health

Device Adverse Event Overview

WEBAbout MAUDE data. The openFDA device adverse event API returns data from Manufacturer and User Facility Device Experience (MAUDE), an FDA dataset that …

Category: Health Go Health

Drug NDC Overview

WEBThe Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, …

Category: Food Go Health

Device Classification Overview

WEBFields Harmonization. Different datasets use different unique identifiers, which can make it difficult to find the same device in each dataset. openFDA features harmonization on …

Category: Health Go Health

Drugs@FDA Overview

WEBFields Harmonization. Different datasets use different unique identifiers, which can make it difficult to find the same drug in each dataset. openFDA features harmonization on …

Category: Health Go Health

Independent Evaluations of COVID-19 Serological Tests

WEBSerology tests detect the presence of antibodies in the blood when the body is responding to a specific infection, like COVID-19. In other words, the tests detect the …

Category: Health Go Health

Device Recall Overview

WEBA 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, …

Category: Medical Go Health

Tobacco Problems Overview

WEBThe U.S. Food and Drug Administration (FDA) regulates all tobacco products in the United States. Tobacco products are made or derived from tobacco and include any associated …

Category: Food Go Health

Manufacturer and User Facility Device Experience

WEBDevice user facilities include hospitals, outpatient diagnostic or treatment facilities, nursing homes and ambulatory surgical facilities. Device user facilities must submit reports when …

Category: Health Go Health