Data / Medical devices / Prosthesis, Esophageal / South Korea
FDA-registered makers of Prosthesis, Esophageal in South Korea: 6 establishments
6 establishments in South Korea are registered with the FDA to make Prosthesis, Esophageal (product code ESW). 5 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Prosthesis, Esophageal
- Product code
- ESW
- Country
- South Korea
Makers of Prosthesis, Esophageal 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 | 7 | October 30, 2025 | 0 | 1 | 0 | api.fda.gov |
| M.i.tech Co., Ltd. | Jeonju Jeonbuk, South Korea | Manufacturer | 4 | October 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| M.I.Tech Co Ltd | Pyeongtaek Gyeonggi, South Korea | Manufacturer | 4 | October 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| M.I.Tech Co., Ltd. | Seoul, South Korea | Specification developer | 4 | October 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Sewoon Medical Co., Ltd. | Cheonan-si Chungnam, South Korea | Manufacturer | 1 | February 22, 2010 | 0 | 0 | 0 | api.fda.gov |
| BCM Co., Ltd. | Goyang-si Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.