DeviceVigil puts a product code’s clearances, recalls and adverse events beside every FDA device record you open, and emails you when any of them change.
Free for every record page. For Chrome and Edge. Launching early 2027.
Checking a single predicate means the 510(k) record, the classification database, the regulation in the eCFR, the recall database, the adverse event search and the summary PDF, each in its own tab and its own search form. DeviceVigil puts all six beside the record you already have open.
Today
With DeviceVigil
Open any 510(k), PMA, De Novo, classification or recall record and the panel is already there: what the record is in one sentence, the product code’s class and regulation, clearances per year, recalls and adverse event counts, and links to the summary and decision letter. No account needed.
Every 510(k), PMA and De Novo number on an FDA page gets a quiet underline. Hover it to see the device, the applicant, the decision and its date, without leaving the page you are reading.
Watch product codes, companies, device names or specific submissions. Each Monday you get one email listing what changed: new clearances, recalls, warning letters and unusual jumps in adverse event reports, each with a link to the official record and a note on why you received it.
Export any table to CSV or Excel. Every row carries its dataset, the dataset’s refresh date and a link to the official record, so the spreadsheet you paste into a risk file or a PMS report can be checked line by line.
Regulatory work has to be cited. DeviceVigil shows which FDA dataset each figure came from, when that dataset was last refreshed and how far behind the live FDA site it runs, with a link to the official record. When a dataset is late or unavailable, the panel says so instead of hiding the row.
Planned pricing at launch. The free tier stays free; paid plans remember what you care about and tell you when it changes.
Join the waitlist and get the extension before the public launch, with Pro free for the first three months.
Thank you. We’ll email you when early access opens.
The extension asks for the fewest permissions it can and does all paid work on our servers, so there is nothing to unlock by editing it and nothing sensitive stored in your browser.
No. DeviceVigil is an independent tool built on the FDA’s public data. It does not change FDA records, and every figure links back to the official source so you can verify it.
From the FDA’s public device datasets published through openFDA: 510(k), PMA, De Novo, classification, recalls and enforcement reports, adverse event reports, UDI, and registration and listing. Each figure shows its dataset and the date that dataset was last refreshed.
Adverse event counts come from openFDA’s device event dataset, which continues to be updated after the FDA moved MAUDE into AEMS in 2026. The panel shows the dataset’s refresh date, so you always know how current a count is.
No. Panels load from a pre-computed index in a fraction of a second, after the FDA page itself has finished loading, and never rearrange the FDA’s own content.
Early access opens to the waitlist first, in order of sign-up. The public Chrome and Edge release follows in early 2027.
