Data / Medical devices / Stents, Drains And Dilators For The Biliary Ducts / South Korea
FDA-registered makers of Stents, Drains And Dilators For The Biliary Ducts in South Korea: 5 establishments
5 establishments in South Korea are registered with the FDA to make Stents, Drains And Dilators For The Biliary Ducts (product code FGE). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Stents, Drains And Dilators For The Biliary Ducts
- Product code
- FGE
- Country
- South Korea
Makers of Stents, Drains And Dilators For The Biliary Ducts in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Taewoong Medical Co., Ltd | Gimpo-Si Gyeonggi, South Korea | Manufacturer | 4 | December 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| M.i.tech Co., Ltd. | Jeonju Jeonbuk, South Korea | Manufacturer | 3 | May 11, 2021 | 0 | 0 | 0 | api.fda.gov |
| M.I.Tech Co Ltd | Pyeongtaek Gyeonggi, South Korea | Manufacturer | 3 | May 11, 2021 | 0 | 0 | 0 | api.fda.gov |
| M.I.Tech Co., Ltd. | Seoul, South Korea | Specification developer | 3 | May 11, 2021 | 0 | 0 | 0 | api.fda.gov |
| Sewoon Medical Co., Ltd. | Cheonan-si Chungnam, South Korea | Manufacturer | 2 | June 16, 2014 | 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.