GUDID device lookup
Paste the UDI from a device label, or search by brand name or company, and see what the device is, who makes it, its product code, and the 510(k) that cleared it. Straight from FDA's GUDID, free and with no signup.
Reading a UDI
A UDI has two parts. The device identifier is fixed for a given version or model, and it is what GUDID is keyed on. The production identifier is the part that changes unit to unit: lot or batch, serial number, manufacturing date, expiry.
In a GS1 string like (01)00616258008684(17)261231, the (01) segment is the device identifier and (17) is an expiry date. Paste the whole thing above and the identifier is extracted for you.
A GUDID record is not evidence of clearance. It means the labeler has submitted identification data for a device in commercial distribution. What authorised it for market is the premarket submission, which is why this tool links the K number through to the 510(k) database search.
Frequently asked questions
- What is GUDID?
- The Global Unique Device Identification Database, FDA's public record of device identifiers. Labelers submit a record for each version or model of a device they market, and the public view is published through AccessGUDID.
- What is a UDI?
- A Unique Device Identifier is the code on a device label. It has two parts: a device identifier, which is fixed for that version or model, and a production identifier such as lot, serial number or expiry, which varies by unit. Only the device identifier is in GUDID.
- Where do I find the UDI on a device?
- On the label or the device itself, usually as a barcode with a human-readable line beneath it. A GS1 string looks like (01)00616258008684(17)261231, where the (01) segment is the device identifier.
- How do I find which 510(k) cleared a device?
- GUDID records list the premarket submission numbers associated with the device. Look the device up here and the K or P number is shown, with K numbers linking through to the clearance record.
- Is a device in GUDID the same as FDA-approved?
- No. GUDID is an identification database, not an approval list. A record means the labeler has submitted device identification data. Whether the device was cleared, approved or exempt is a separate question answered by the premarket submission.
- Is this data official?
- It comes directly from FDA's openFDA API, and every device links to its AccessGUDID record so you can verify it at source. FDA updates the dataset periodically, so very recent records may not appear immediately.
Related
- FDA 510(k) database search — find clearances and predicate candidates
- What is GxP? — including the QMSR that replaced 21 CFR 820 in February 2026
Beyond the identifier
Arca reads GUDID, clearance records and your own technical file together, and drafts the comparison and gap analysis with every claim cited back to its source.