What is the FDA MAUDE database?
MAUDE contains medical device reports submitted to FDA by manufacturers, importers, device user facilities, health professionals, patients, and consumers. It is used to identify potential post-market safety signals.
Free FDA data search · No signup
FDA MAUDE Database & Medical Device Adverse Event Search
Search public FDA medical device reports by device name, manufacturer, product code, report number, or 510(k)/PMA number. Inspect the actual report—not an AI summary.
Direct openFDA dataEvent-type filtersLinks to FDA report details
Find specific reports
Search by product, company, FDA code, MDR report, or premarket submission.
Use current source data
Results come from the FDA device event dataset and show its latest update date.
Verify every result
Each result links to its FDA MAUDE detail page for source review.
Search FDA medical device reports
Search public MAUDE reports by device, company, FDA product code, report number, or submission number.
Try:
DJ Fang
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?
How to interpret MAUDE results
A report does not prove that a device caused an event. Reporting practices and device use vary, so report counts cannot be used to calculate incidence rates or compare device safety. Review the underlying FDA report and use the results as a signal for further investigation.
How to use FDA MAUDE in regulatory research
Start with a generic device name or FDA product code, then narrow the results by date and event type. Product codes are usually the most precise way to review a defined FDA device category; manufacturer and brand searches are useful for complaint-pattern research.
Read the report narrative, submission number, product code, event date, and follow-up status together. One report can have multiple follow-ups, and the submitted narrative may change as the manufacturer investigates.
Treat the results as a signal, not a verdict. Combine MAUDE review with recalls, 510(k) or PMA records, labeling, complaint trending, and risk-management evidence before drawing a regulatory or safety conclusion.
FDA MAUDE search FAQ
Does a MAUDE report prove that a device caused an injury or death?
No. A report describes an allegation or event submitted to FDA. It does not by itself establish causation, defect, or the frequency of an event.
Can MAUDE report counts be used to compare device safety?
No. The number of devices in use and the completeness of reporting are generally unknown, so report counts are not incidence rates and should not be used alone to compare products.
How current is this MAUDE search?
This tool queries the openFDA device event API and displays the source data update date with each search. openFDA states that the device event dataset is updated weekly.