Data / Medical devices / Intrauterine Tamponade Balloon
Intrauterine Tamponade Balloon (OQY): 5 FDA-registered makers in 1 country
5 establishments in 1 country are registered with the FDA to make Intrauterine Tamponade Balloon (product code OQY, Class 2, 21 CFR 884.4530). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on May 15, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OQY
- Device class
- 2
- Regulation
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
Makers of Intrauterine Tamponade Balloon
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Gi Supply | Mechanicsburg, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | May 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer, Specification developer | 2 | October 28, 2022 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 1 | October 28, 2022 | 0 | 0 | 0 | api.fda.gov |
| Utah Medical Products, Inc. | Midvale, UT, United States | Manufacturer | 1 | January 11, 2011 | 0 | 0 | 0 | api.fda.gov |
| Xeridiem Medical Devices | Tucson, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 15, 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.