Data / Medical devices / Needle, Hypodermic, Single Lumen / South Korea
FDA-registered makers of Needle, Hypodermic, Single Lumen in South Korea: 17 establishments
17 establishments in South Korea are registered with the FDA to make Needle, Hypodermic, Single Lumen (product code FMI). 12 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
- Needle, Hypodermic, Single Lumen
- Product code
- FMI
- Country
- South Korea
Makers of Needle, Hypodermic, Single Lumen in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Feel Tech Bio Co., Ltd. | Dongnam-gu, Cheonan-si Chungnam, South Korea | Contract manufacturer, Manufacturer | 3 | December 23, 2011 | 0 | 0 | 0 | api.fda.gov |
| Shina Corp. | GONGJU-SI Chungnam, South Korea | Exporter to the US, Manufacturer | 3 | March 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Tae-Chang Industrial Co., Ltd. | Gumi-si Gyeongbuk, South Korea | Contract sterilizer, Manufacturer | 3 | June 27, 2018 | 0 | 0 | 0 | api.fda.gov |
| ACE MEDICAL INDUSTRy CO., LTD. | Yangju-si Gyeonggi, South Korea | Manufacturer | 2 | January 8, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medexel Co., Ltd. | Anseong-si Gyeonggi, South Korea | Contract manufacturer, Manufacturer | 2 | July 24, 2018 | 0 | 0 | 0 | api.fda.gov |
| Shina Med Corporation | Anseong-si Gyeonggi, South Korea | Contract manufacturer, Manufacturer | 2 | April 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Feeltech Co.,ltd. | Gunsan-si Jeonbuk, South Korea | Complaint file establishment, Exporter to the US, Manufacturer | 1 | January 14, 2010 | 0 | 0 | 0 | api.fda.gov |
| Medifirst Co.,Ltd. | Cheonan-si, Chungnam, South Korea | Manufacturer | 1 | June 4, 2008 | 0 | 0 | 0 | api.fda.gov |
| Shinchang Medical Co., Ltd. | Gumi-si Gyeongbuk, South Korea | Manufacturer | 1 | August 23, 2007 | 0 | 0 | 0 | api.fda.gov |
| Sungshim Medicare Co.,Ltd. | Anseong-si Gyeonggi, South Korea | Manufacturer | 1 | March 17, 2016 | 0 | 0 | 0 | api.fda.gov |
| W.l.med Co., Ltd. | Anseong-si Gyeonggi, South Korea | Contract manufacturer, Manufacturer | 1 | May 25, 2022 | 0 | 0 | 0 | api.fda.gov |
| Yong Chang Co., Ltd. | Gimpo Gyeonggi, South Korea | Contract manufacturer, Manufacturer | 1 | September 21, 2016 | 0 | 0 | 0 | api.fda.gov |
| Custom Tube Manufacturing LLC | Yangju-si Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HLB Life Science Co., Ltd. | Anseong-si, Gyeonggi-do, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jeil Tech Co.,ltd | Sejong-si Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jung Rim Medical Industrial Co., Ltd. | JINCHEON-GUN Chungbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tae-Chang Industrial Co., Ltd. | Gongju-si Chungnam, South Korea | Contract 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.