GUDID is the FDA's Global Unique Device Identification Database, searchable through AccessGUDID. Here is how to look up a device by its UDI, what a GUDID record contains, how to download the whole database, and how ClinicaLister ties device identifiers to clearances, safety records and trials.
Under the FDA's Unique Device Identification (UDI) system, most devices carry a UDI on their label. The UDI has two parts: the device identifier (DI), which identifies the labeler and the specific version or model, and the production identifier (PI) — lot, serial number, expiry or manufacturing date.
GUDID is the FDA-administered database of device identifier records submitted by device labelers. The DI is the key; each record carries the label information for that version or model — brand name, version or model number, company, device description, GMDN term, FDA product code and premarket submission number, sterility and MRI safety information, and commercial distribution status.
GUDID does not hold production identifiers or any patient or user information. AccessGUDID, built by the National Library of Medicine with the FDA, is the public window onto it: a search interface, an API and full downloads.
AccessGUDID covers a single lookup through to analysing the whole database.
On AccessGUDID, paste a device identifier (or a full UDI barcode string) to go straight to its record, or search by brand name, company or device description.
Each record shows the FDA product code and the premarket submission number (the 510(k) or PMA it was marketed under), alongside size, sterility, MRI safety and commercial distribution status.
Use the submission number to open the 510(k) or PMA record, and the product code to find comparable devices and their adverse event reports.
The AccessGUDID API returns a device record as JSON from its DI, for example /api/v3/devices/lookup.json?di=…, which suits checking a list of identifiers in bulk.
For analysis across all devices, download the full GUDID release and keep it current with the daily, weekly or monthly update files.
ClinicaLister joins GUDID records to FDA 510(k) and PMA records by submission number, so a device's many identifiers roll up under the submission that cleared it.
Through that device record, identifiers sit next to the device's adverse event reports, recalls and linked clinical trials.
GUDID is refreshed daily from the AccessGUDID update files, so new listings and distribution-status changes come through without a manual download.
Through the ClinicaLister MCP server, an AI assistant can list the GUDID records for a device or company alongside its regulatory history.
5.1M+
GUDID device identifier records
Daily
sync from AccessGUDID
About 1 in 3
records joined to a 510(k) or PMA
Counts measured on the ClinicaLister platform database, August–September 2026. ClinicaLister holds the full GUDID. Records join to a 510(k) or PMA only where the submission number matches one we hold; the rest are searchable on their own.
GUDID is the FDA database that device labelers submit to. AccessGUDID is the public site, API and download service, run by the National Library of Medicine with the FDA, through which anyone can search it.
It is the device identifier part of a Unique Device Identifier. It identifies the labeler and the specific version or model of a device, and it is the key for a GUDID record. The production identifier (lot, serial, dates) is not stored in GUDID.
Yes. AccessGUDID offers the full release as a download, plus daily, weekly and monthly update files to keep a copy current.
No. Use the FDA recall database and MAUDE for those. ClinicaLister shows them next to the device's GUDID records where they can be matched.
Resolve device identifiers to clearances, safety and trials
Built for the Device / MedTech Professional. See it in the product: Drug & Device Details. All data sources