Free FDA data search · No signupFDA 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.
Search FDA medical device reports
Search public MAUDE reports by device, company, FDA product code, report number, or submission number.
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 narrative may change as the manufacturer investigates.
Treat the results as a signal, not a verdict. MAUDE does not tell you how many devices were in use, whether the device caused the reported event, the true frequency of a problem, or whether one product is safer than another. Combine MAUDE review with recalls, 510(k) or PMA records, labeling, complaint trending, and risk-management evidence before drawing a regulatory or safety conclusion.
- 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.
- 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.
- 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.
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