Data / Medical devices / Taiwan / BioGend Therapeutics Co., Ltd
BioGend Therapeutics Co., Ltd: FDA-registered device maker in Taipei City, Taiwan, 1 510(k) clearance
BioGend Therapeutics Co., Ltd is registered with the FDA (registration 3014346934) in Taipei City, Taiwan. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 6, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014346934
- Address
- 4F., No.3-2, Park St., Nangang Dist., Taipei City, Taiwan, 11503
- Owner or operator
- BioGend Therapeutics Co., Ltd. (10048901)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 11, 2018
- Registered through
- 2026
- Brand names listed
- BioGend Cartilage Processor, Reveille Cartilage Processor, Soufcut Soft Tissue Processor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Specification developer | accessdata.fda.gov |
| Spatula, Surgical, General & Plastic Surgery | GAF | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 6, 2024 | K233075 | BioGend Interbody Fusion System 001 Cage | MAX | Substantially Equivalent | Biogend Therapeutics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Spatula, Surgical, General & Plastic Surgery
Updated March 6, 2024. 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.