Research / DeviceEstablishmentPulse
New FDA Medical Device Listings by Manufacturer, CMO & Sterilizer: 2026 statistics from 2,570 public records
California leads with 284 of 2,570 records (11.1%), ahead of Illinois with 95 (3.7%) (as of 2026-10-28; source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
Key findings
- Zalwin's DeviceEstablishmentPulse dataset holds 2,570 DeviceEstablishmentPulse records dated 2026-05-01 to 2026-10-19 (as of 2026-10-28; source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)). #
- California leads with 284 of 2,570 records (11.1%), ahead of Illinois with 95 (3.7%) (as of 2026-10-28; source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)). #
- The most common establishment role is Manufacturer: 1,173 of 2,570 records (45.6%) (as of 2026-10-28; source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)). #
- Across 2,570 records with a stated amount, the total is 10,978 and the median is 1; the largest is 336 (Titanlinks Logistics LLC (repackager or relabeler, Newark, DE)) (as of 2026-10-28; source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)). #
- The top 10% of records by amount (257 of 2,570) account for 59.1% of the total (as of 2026-10-28; source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)). #
- 166 of 2,570 records (6.5%) are dated within the 30 days before 2026-10-28 (source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)). #
- In California, the leading establishment role is Manufacturer with 129 of 284 records (45.4%) (as of 2026-10-28; source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)). #
DeviceEstablishmentPulse records by state
| Group | Records | Share |
|---|---|---|
| California | 284 | 11.1% |
| Illinois | 95 | 3.7% |
| Florida | 84 | 3.3% |
| Indiana | 73 | 2.8% |
| Massachusetts | 70 | 2.7% |
| Texas | 68 | 2.6% |
| New York | 56 | 2.2% |
| New Jersey | 49 | 1.9% |
| Pennsylvania | 44 | 1.7% |
| Georgia | 43 | 1.7% |
DeviceEstablishmentPulse records by establishment role
| Group | Records | Share |
|---|---|---|
| Manufacturer | 1,173 | 45.6% |
| Contract manufacturer | 527 | 20.5% |
| Specification developer (outsources manufacturing) | 336 | 13.1% |
| Repackager or relabeler | 192 | 7.5% |
| Foreign exporter | 155 | 6.0% |
| Other | 93 | 3.6% |
| Contract sterilizer | 91 | 3.5% |
| Remanufacturer | 3 | 0.1% |
Methodology and data provenance
- Sample: 2,570 public records dated 2026-05-01 to 2026-10-19; illustrative samples excluded.
- Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration). Refreshed automatically about every 168 hours; figures above are as of 2026-10-28.
- Shares are of all records in the dataset; totals and medians use only records with a stated amount.
- Organization-level data only. Informational; verify individual records at the official source.
Cite this study
Zalwin Research, "DeviceEstablishmentPulse statistics" (data as of 2026-10-28), https://zalwin.com/research/deviceestablishmentpulse
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