Data / Medical devices / Endoscopic Ultrasound System, Gastroenterology-Urology / United States
FDA-registered makers of Endoscopic Ultrasound System, Gastroenterology-Urology in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Endoscopic Ultrasound System, Gastroenterology-Urology (product code ODG). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Endoscopic Ultrasound System, Gastroenterology-Urology
- Product code
- ODG
- Country
- United States
Makers of Endoscopic Ultrasound System, Gastroenterology-Urology in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 8 | June 17, 2026 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer | 8 | June 17, 2026 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 8 | June 17, 2026 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 7 | December 30, 2022 | 0 | 0 | 0 | api.fda.gov |
| Endosound Inc | Portland, OR, United States | Complaint file establishment, Manufacturer | 1 | December 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| United States Endoscopy Group, Inc. | Mentor, OH, United States | Complaint file establishment, Specification developer | 1 | April 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Apex Medical Technologies, Inc. | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.