An inventory of all FDA Datasets

This file contains the data elements used for searching the FDA Online Data Repository including proprietary name, active ingredients, marketing application number or regulatory citation, National Drug Code, and company name.

The drug labels and other drug-specific information on this Web site represent the most recent drug listing information companies have submitted to the Food and Drug Administration (FDA). (See 21 CFR part 207.) The drug labeling and other information has been reformatted to make it easier to read but its content has neither been altered nor verified by FDA. The drug labeling on this Web site may not be the labeling on currently distributed products or identical to the labeling that is approved. Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies described in monographs. Drugs marked 'OTC monograph final' or OTC monograph not final' are not checked for conformance to the monograph. Drugs marked 'unapproved medical gas', 'unapproved homeopathic' or 'unapproved drug other' on this Web site have not been evaluated by FDA for safety and efficacy and their labeling has not been approved. In addition, FDA is not aware of scientific evidence to support homeopathy as effective.

Contains data for FDA recalls from 2009 through the present.

This database contains medical device names and associated information developed by the Center. It includes a three letter device product code and a Device Class that refers to the level of CDRH regulation of a given device.

The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases including Premarket Approvals (PMA), Premarket Notifications (510[k]), Adverse Events, and Recalls. You can search the TPLC database by device name or procode to receive a full report about a particular product line.

This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution) and listings of medical devices in commercial distribution by both domestic and foreign manufacturers. Note: This database is updated once a week.

This dataset represents all technologies available for licensing from the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Center for Disease Control and Prevention (CDC).

Contains data for FDA pistachio product recalls since March 2009.

This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information the Center can use to make an appropriate decision regarding the clearance or approval of a submission. Information submitted on conformance with such standards will have a direct bearing on safety and effectiveness determinations made during the review of IDEs, HDEs, PMAs, and PDPs. Conformance with recognized consensus standards in and of itself, however, may not always be a sufficient basis for regulatory decisions.

The FDA Acronyms and Abbreviations database provides a quick reference to acronyms and abbreviations related to Food and Drug Administration (FDA) activities

Information provided to FDA by manufacturers about current drugs in shortage, resolved shortages, and discontinuations of specific drug products.

This blog post was posted on September 4, 2015 and written by Taha Kass-Hout, M.D., M.S., Roselie A. Bright, Sc.D., M.S., P.M.P. and Ann Ferriter. It is a cross post from FDA Voice.

This database allows you to search the CDRH's database information on medical devices which may have malfunctioned or caused a death or serious injury during the years 1992 through 1996.

The Approved Drug Products with Therapeutic Equivalence (Orange Book or OB) is a list of drugs approved under Section 505 of the Federal Food, Drug and Cosmetic Act and provides consumers timely updates on these products. In addition to these products (fo

The FDA Peanut-Containing Product Recall widget allows you to browse the Food and Drug Administration (FDA) database of peanut butter and peanut-containing products subject to recall. This database makes it easier for you to determine whether any of the products you have at home are subject to recent recalls, and will be updated as new information becomes available.

This database contains a list of classified medical device recalls since November 1, 2002

Sourced from FDA website on Nov 15, 2022.

From the website

Contents of this list: This list contains publicly available information on AI/ML-enabled devices. The FDA assembled this list by searching FDA’s publicly-facing information, as well as by reviewing information in the publicly available resources cited below (*) and in other publicly available materials published by the specific manufacturers.

This list is not meant to be an exhaustive or comprehensive resource of AI/ML-enabled medical devices. Rather, it is a list of AI/ML-enabled devices across medical disciplines, based on publicly available information.

Updates to this list: The FDA plans to update this list on a periodic basis based on publicly available information. Send questions or feedback on this list to digitalhealth@fda.hhs.gov.

This blog post was posted by by Taha A. Kass-Hout, M.D., M.S. on December 15, 2015. It was written by Taha A. Kass-Hout, M.D., M.S. and Elaine Johanson

Contains data for FDA pet food recalls since January 1, 2006.