Data / Medical devices / Orthopedic Manual Surgical Instrument / Taiwan
FDA-registered makers of Orthopedic Manual Surgical Instrument in Taiwan: 13 establishments
13 establishments in Taiwan are registered with the FDA to make Orthopedic Manual Surgical Instrument (product code LXH). 0 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
- Orthopedic Manual Surgical Instrument
- Product code
- LXH
- Country
- Taiwan
Makers of Orthopedic Manual Surgical Instrument in Taiwan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Baui Biotech Co., Ltd. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foxxmed Ltd | Ilan Yilan, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intai Technology Corp. Implants Business Unit | Taichung City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microware Precision Co., Ltd. | Taichung, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| New Deantronics Taiwan Ltd. | New Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| New Deantronics Taiwan Ltd. - Chiayi | Chiayi County Chiayi(County), Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paonan Biotech Co., Ltd | Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Engineered Products, Inc. | Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remex Medical Corp. | Taichung, Taiwan | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Syntec Scientific Corp. | CHANG HUA Changhua, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Orthopedic Corp. | Kaohsiung, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 3 | 0 | api.fda.gov | |
| United Orthopedic Corporation | Hsinchu Hsinchu(County), Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wiltrom Corporation Limited | Zhubei City Hsinchu(County), Taiwan | Complaint file establishment, 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.