Data / Medical devices / Suture, Surgical, Absorbable, Polydioxanone / South Korea
FDA-registered makers of Suture, Surgical, Absorbable, Polydioxanone in South Korea: 10 establishments
10 establishments in South Korea are registered with the FDA to make Suture, Surgical, Absorbable, Polydioxanone (product code NEW). 7 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Suture, Surgical, Absorbable, Polydioxanone
- Product code
- NEW
- Country
- South Korea
Makers of Suture, Surgical, Absorbable, Polydioxanone in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Hans Biomed Corp. | Daejeon, South Korea | Exporter to the US, Manufacturer | 4 | September 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Feeltech Co.,ltd. | Gunsan-si Jeonbuk, South Korea | Exporter to the US, Manufacturer | 3 | October 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hyundae Meditech Co., Ltd. | Wonju Gangwon, South Korea | Manufacturer | 2 | September 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| Y.jacobs Medical Inc. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 2 | November 23, 2016 | 0 | 0 | 0 | api.fda.gov |
| Dongwon Medical Co.,ltd. | Gwangsan-gu Gwangju, South Korea | Manufacturer | 1 | November 22, 2016 | 0 | 0 | 0 | api.fda.gov |
| Meditime Co., Ltd | Won Ju Gangwon, South Korea | Manufacturer, Repackager or relabeler | 1 | August 15, 2019 | 0 | 0 | 0 | api.fda.gov |
| Samyang Biopharm Corp. | Daedeok-gu Daejeon, South Korea | Manufacturer | 1 | August 25, 2026 | 0 | 0 | 0 | api.fda.gov |
| Skidyworks International Co., Ltd | Jeju, South Korea | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smeng Co.,ltd. | Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yurim Medical Co.,ltd | Cheongju-si Chungbuk, South Korea | Contract manufacturer, Contract sterilizer | 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.