The data section of your PSUR,
done in seconds
Every PSUR needs a survey of public vigilance databases — adverse events, recalls, and safety trends for your device and similar devices. Stop clicking through MAUDE by hand: enter your FDA product code and get charts, tables, and an audit-ready methodology block. Free.
Adverse event trends
MAUDE event counts by month and by type — deaths, injuries, malfunctions — with prior-period comparison and the most-reported coded device and patient problems.
Recalls & enforcement
All FDA recalls for your product code in the reporting period, with reasons, status, and Class I/II/III enforcement classifications.
Audit-ready methodology
Which datasets were queried, with which filters, when, and with what coverage — the reproducible search protocol Notified Body auditors ask for.
How it works
Enter your product code
One or more 3-letter FDA product codes, your reporting period, and optionally your device or manufacturer names to split "your device" from the market baseline.
Review the report
Charts and tables over 25 million FDA adverse events, recalls, and enforcement reports — rendered in seconds, honestly labeled, every number traceable.
Save, share, export
Save reports with a stable URL (free reports are public, Pro keeps them private), download tables as CSV, or print the whole report to PDF.
See a live example
Public reportsFree forever — Pro when your work is confidential
- ✓ Unlimited reports, any product code and period
- ✓ All charts, tables, and the methodology block
- ✓ Unlimited saved reports — always public
- ✓ Private reports — client work stays confidential
- ✓ CSV downloads for every table
- ✓ Print/PDF export view
Why PSUR database searches take so long by hand
Under the EU MDR, manufacturers of Class IIa devices and above must produce a Periodic Safety Update Report on a fixed schedule, and Class I manufacturers a PMS report. Both require surveying publicly available vigilance data for your own device and similar devices on the market — in practice, the FDA's MAUDE database and FDA recall records, since EUDAMED's vigilance module is not publicly accessible.
Done manually, that means paging through MAUDE search results, exporting, deduplicating, counting by event type, and trending across the reporting period — then writing down your search protocol precisely enough that an auditor could repeat it. Hours per report, repeated every reporting cycle. This tool runs the same protocol in seconds over the complete openFDA datasets and documents every filter it applied. For the full manual protocol (and when you'd still use it), see our guides on the PSUR database search, searching MAUDE, and the FDA recalls database.