Data / Medical devices / Agents, Embolic, For Treatment Of Uterine Fibroids
Agents, Embolic, For Treatment Of Uterine Fibroids (NAJ): 11 FDA-registered makers in 6 countries
11 establishments in 6 countries are registered with the FDA to make Agents, Embolic, For Treatment Of Uterine Fibroids (product code NAJ, Class 2, 21 CFR 870.3300). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on December 21, 2023, and lists 1 recall event (0 Class I). FDA data exported November 3, 2026.
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- Product code
- NAJ
- Device class
- 2
- Regulation
- 870.3300
- Medical specialty
- Cardiovascular
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Costa Rica | 1 |
| Ireland | 1 |
| France | 1 |
| Netherlands | 1 |
| China | 1 |
Makers of Agents, Embolic, For Treatment Of Uterine Fibroids
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 |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | La Aurora Heredia, Costa Rica | Specification developer | 1 | April 16, 2010 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | CORK Munster, Ireland | Manufacturer | 1 | April 16, 2010 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 1 | December 23, 2008 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Specification developer | 1 | June 7, 2013 | 0 | 0 | 0 | api.fda.gov |
| Biosphere Medical, S.A. | Roissy Val-d'Oise, France | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Maple Grove, MN, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific International BV, European Dist. Ctr. | KERKRADE Limburg, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MicroVention, Inc. | Aliso Viejo, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Varian Medical Systems, Inc | Austin, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 21, 2023. 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.