Event510(k) cleared
Effective2026-09-13
DecisionSESE
DeviceSignal
Know which medtech firms just had a recall classified or a device cleared
Commercial triggers for eQMS vendors and regulatory consultancies, built only from published FDA records with the source evidence attached to every signal.
See a real week of signals
$149/month
792 signals published, a sample of them public. No account needed.
The three most recent DeviceSignal signals
Event510(k) cleared
Effective2026-09-12
DecisionSESE
Event510(k) cleared
Effective2026-09-12
DecisionSESE
What you get
- Every signal links to the exact FDA record, snapshot hash and publication date it came from
- Class I and Class II recall classifications, plus new 510(k) clearances, keyed to the firm
- A subscriber feed you can filter by firm, signal type and effective date
- Freshness is measured and shown per signal, not promised
Pricing
$149/month
Recurring monthly subscription. Cancel any time from the receipt; access runs to the end of the period you paid for.
- Every signal we publish for this market, not a sample
- Filter by company, signal type and effective date
- Each row linked to the source record and snapshot behind it
- Access by a link that works from any browser, sent on your receipt
Checkout opening soon
Checkout opens once our merchant of record finishes reviewing the store. Everything else on this page is live now: the signals above are real and refreshed daily, and the public sample needs no account.
Be told when checkout opens
Leaving your address records your interest. Email sending is not switched on yet, so nothing will be sent until it is - we would rather say that than promise a message that cannot arrive. Every sample signal is already public above; nothing is held behind this form.
Email me DeviceSignal product updates and the sample. I can unsubscribe at any time, and my address will not be shared or sold. (consent text 2026-09-08.1)
Why trust this
- Built only from official U.S. government records, named on the data sources page with the terms each one imposes.
- Every signal carries its source record id and a hash of the snapshot it came from, so you can check it against the agency yourself.
- A signal exists because a versioned rule fired over verified source data. No language model writes, rewrites or infers a fact.
- Freshness is measured per run and shown with the data rather than promised.
What this is not
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)