Data / Medical devices / Orthopedic Manual Surgical Instrument / Malaysia
FDA-registered makers of Orthopedic Manual Surgical Instrument in Malaysia: 9 establishments
9 establishments in Malaysia 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 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Orthopedic Manual Surgical Instrument
- Product code
- LXH
- Country
- Malaysia
Makers of Orthopedic Manual Surgical Instrument in Malaysia
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| 3D Instrumentation Sdn Bhd | Bukit Mertajam Pulau Pinang, Malaysia | Contract manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalanche Med Sdn Bhd | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Medical Industries Sdn. Bhd. | PENANG Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hamagawa Industrial (M) Sdn Bhd | Sungai Petani Kedah, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho Solutions Sdn Bhd | Prai, Penang Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Perai Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Bandar Cassia Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Malaysia Sdn Bhd (758243-M) | Bayan Lepas Pulau Pinang, Malaysia | 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.