Data / Medical devices / Unit, X-Ray, Extraoral With Timer / South Korea
FDA-registered makers of Unit, X-Ray, Extraoral With Timer in South Korea: 13 establishments
13 establishments in South Korea are registered with the FDA to make Unit, X-Ray, Extraoral With Timer (product code EHD). 13 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
- Unit, X-Ray, Extraoral With Timer
- Product code
- EHD
- Country
- South Korea
Makers of Unit, X-Ray, Extraoral With Timer in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Digimed Co., Ltd | Seoul, South Korea | Manufacturer | 5 | March 3, 2023 | 0 | 1 | 0 | api.fda.gov |
| Vatech Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 4 | October 26, 2022 | 0 | 0 | 0 | api.fda.gov |
| Genoray Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 3 | December 8, 2023 | 0 | 0 | 0 | api.fda.gov |
| HDX Will Corp. | Heungdeok-gu, Cheongju-si, Chungcheongbuk-do Chungbuk, South Korea | Manufacturer | 2 | December 27, 2019 | 0 | 0 | 0 | api.fda.gov |
| Remedi Inc. | Chuncheon Gangwon, South Korea | Manufacturer | 2 | May 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| DRTECH Corporation | Seongnam-si Gyeonggi, South Korea | Manufacturer | 1 | November 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| ECOTRON Co., Ltd. | Seoul, South Korea | Manufacturer | 1 | June 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| Osstem Implant Co., Ltd. | Gangseo-gu Seoul, South Korea | Specification developer | 1 | November 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Osstem Implant Co.,ltd. | Yeonsu-gu Incheon, South Korea | Manufacturer | 1 | November 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| PDX Co., Ltd. | Anyang-Si Gyeonggi, South Korea | Manufacturer | 1 | May 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| PICOPACK Inc. | Daejeon, South Korea | Manufacturer | 1 | July 30, 2024 | 0 | 0 | 0 | api.fda.gov |
| Poskom Co., Ltd | Goyang-si Gyeonggi, South Korea | Contract manufacturer, Manufacturer | 1 | July 31, 2013 | 0 | 0 | 0 | api.fda.gov |
| Vsi Co., Ltd. | Cheongju-si Chungbuk, South Korea | Manufacturer | 1 | June 29, 2022 | 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.