Device Data Snapshot
What the public medical device record actually holds — every openFDA dataset with its size and export date, and per-product-code counts of clearances, recalls, listings and device identifiers.
Three letters is a product code. Anything longer is matched against the device name.
| What the record holds | Records |
|---|
| Dataset | Records | Exported | Bulk size |
|---|---|---|---|
| 510(k) clearances | 176,070 | 2026-09-14 | 237 MB |
| PMA approvals and supplements | 57,101 | 2026-09-14 | 21 MB |
| MAUDE adverse event reports | 26,136,889 | 2026-09-15 | 18.0 GB |
| Device recalls | 59,160 | 2026-09-15 | 274 MB |
| Recall enforcement reports | 39,949 | 2026-09-15 | 90 MB |
| Establishment registrations and listings | 335,224 | 2026-09-14 | 82 MB |
| GUDID device identifiers | 5,182,695 | 2026-09-15 | 1.9 GB |
| Product code classifications | 7,093 | 2026-09-14 | 3 MB |
MAUDE adverse event reports is the largest by a wide margin at 26,136,889 records across 371 bulk files. It cannot be paged through the API — openFDA stops at a skip of 25,000 — so anything built on it is a bulk load rather than a query.
openFDA returns at most 1,000 aggregation terms per measure. There are 7,093 product codes, so this index holds the busiest 1,000 per measure — 1,835 codes once the four lists are combined. The other 5,258 are absent from the index, which means they are outside the busiest thousand. It does not mean they have no records.
| Measure | Terms | Counted | Share of endpoint |
|---|---|---|---|
| 510(k) clearances | 1,000 | 150,943 | 85.7% |
| Device recalls | 1,000 | 54,212 | 91.6% |
| GUDID device identifiers | 1,000 | 6,262,979 | n/a — code mentions |
| Establishment registrations and listings | 1,000 | 344,315 | n/a — code mentions |
Listings and device identifiers count code mentions, not records: one device can carry several product codes, so those sums legitimately exceed the record count and a coverage share would be meaningless. Every figure on this page is a count of public records — not of devices, companies, procedures or sales.
The brief
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