Search the US FDA Device Databases
Live search across openFDA: 510(k) clearances, adverse events (MAUDE), recalls, enforcement reports, PMA approvals, device classification, UDI/GUDID, and registration & listing. Filter, sort, cross-link by product code, and export to Excel or Word.
Details
In short: This page searches the FDA's public device databases live: 510(k) clearances, PMA approvals, MAUDE adverse event reports, recalls, enforcement actions, product classification, UDI records, and establishment registration and listing. Data comes directly from the openFDA API. No account is required and nothing is stored.
Which FDA databases can you search here
Each tab queries a different openFDA endpoint. They are separate datasets with separate update schedules, so a device may appear in one and not another.
| Dataset | What it contains | Typical use |
|---|---|---|
| 510(k) | Premarket notification clearances, including the decision date and product code | Confirm a device is cleared and find its K number |
| PMA | Premarket approval records for Class III devices | Check approval and supplement history |
| MAUDE | Adverse event reports submitted to the FDA | Review reported failures and injuries for a device or manufacturer |
| Recalls | Device recall records with classification and reason | Check whether a device or lot has been recalled |
| Enforcement | Enforcement reports tied to recall actions | See the formal action and its status |
| Classification | Product codes, device class and regulation number | Establish the regulatory class and pathway |
| UDI | Unique Device Identification records from GUDID | Resolve a device identifier to its labelling data |
| Registration and listing | Registered establishments and the devices they list | Identify manufacturers and their registered sites |
How current is the data
Results are fetched from openFDA at the moment you search, so they are as current as the FDA's own published extracts. The FDA refreshes these datasets on its own schedule, and the refresh interval differs by dataset. A very recent clearance or report may not appear immediately.
What this page cannot tell you
These are administrative records, not clinical conclusions. A MAUDE report is an allegation submitted to the FDA and is not confirmation that a device caused harm; the FDA states that reports are not independently verified and cannot be used alone to compare device safety. A 510(k) clearance means substantial equivalence to a predicate, not a demonstration of clinical benefit.
Frequently asked questions
Is this the official FDA database?
No. This page queries the FDA's public openFDA API and presents the results. The FDA remains the source of record, and every result links back to it.
Do I need an account or a licence?
No. The search is free, requires no account, and the underlying FDA data is public domain.
Why does a device appear in one dataset but not another?
The datasets are maintained separately. A cleared device with no reported problems will appear under 510(k) but not in MAUDE or recalls.
Can I export the results?
Yes. Results can be exported for further analysis from within the tool.
What is the difference between a 510(k) and a PMA?
A 510(k) demonstrates substantial equivalence to a legally marketed predicate device and covers most Class II devices. A PMA is the more demanding approval route required for most Class III devices.