Data / Medical devices / Respirator, Surgical / South Korea
FDA-registered makers of Respirator, Surgical in South Korea: 8 establishments
8 establishments in South Korea are registered with the FDA to make Respirator, Surgical (product code MSH). 2 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Respirator, Surgical
- Product code
- MSH
- Country
- South Korea
Makers of Respirator, Surgical in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Hydrochem Co., Ltd | Gangeung-Si Gangwon, South Korea | Manufacturer | 1 | January 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Kbbio Co., Ltd. | Seongnam Gyeonggi, South Korea | Manufacturer | 1 | January 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| BK Medicare Co., Ltd. | Yangsan Gyeongnam, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evergreen Co.,ltd | Gyeonggido, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kyungin Flax Co.,ltd | Ansan-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lty Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LTY Jeonju Factory Co., Ltd. | Wanju-gun Jeonbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tia | Gimje-si Jeonbuk, South Korea | Manufacturer | 0 | 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.