Data / Medical devices / Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia (NOY): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia (product code NOY, Class 2, 21 CFR 876.5550). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on April 20, 2021, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NOY
- Device class
- 2
- Regulation
- 876.5550
- Medical specialty
- Gastroenterology, Urology
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Ireland | 1 |
| Netherlands | 1 |
| France | 1 |
Makers of Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
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 | Maple Grove, MN, United States | Specification developer | 2 | April 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | CORK Munster, Ireland | Manufacturer | 2 | April 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 1 | April 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific International BV, European Dist. Ctr. | KERKRADE Limburg, Netherlands | Manufacturer | 1 | April 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| MicroVention, Inc. | Aliso Viejo, CA, United States | Manufacturer | 1 | January 22, 2020 | 0 | 1 | 0 | api.fda.gov |
| Varian Medical Systems, Inc | Austin, TX, United States | Manufacturer, Repackager or relabeler | 1 | April 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Biosphere Medical, S.A. | Roissy Val-d'Oise, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 20, 2021. 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.