Data / Medical devices / Taiwan / Formosa Biomedical Technology Corporation
Formosa Biomedical Technology Corporation: FDA-registered device maker in Taipei, Taiwan, 5 510(k) clearances
Formosa Biomedical Technology Corporation is registered with the FDA (registration 3007699035) in Taipei, Taiwan. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 5, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007699035
- Address
- F5F, 105 Tung Hwa North Road, Taipei, Taiwan, 105
- Owner or operator
- Formosa Biomedical Technology Corporation (10029585)
- Roles
- Manufacturer
- First device listed
- June 2, 2009
- Registered through
- 2026
- Brand names listed
- A-GRIX Resorbable Bone Void Filler, A-GRIX TE Resorbable Bone Void Filler, CALTRIX Resorbable Bone Void Filler, DISPENSER, CEMENT, MIXER, CEMENT, FOR CLINICAL USE, WELLGRAFT PE I Resorbable Bone Void Filler, WELLGRAFT PE II Resorbable Bone Void Filler
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dispenser, Cement | KIH | 1 | Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Manufacturer | accessdata.fda.gov |
| Mixer, Cement, For Clinical Use | JDZ | 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 |
|---|---|---|---|---|---|---|
| February 5, 2013 | K121453 | A-GRIX TE RESORABLE BONE VOID FILLER | MQV | Substantially Equivalent | Ag Digital Technology Corp. | accessdata.fda.gov |
| March 2, 2010 | K091688 | A-GRIX RESORBABLE BONE VOID FILLER | MQV | Substantially Equivalent | Ag Digital Technology Corp. | accessdata.fda.gov |
| January 28, 2009 | K083279 | CALTRIX RESORBABLE BONE VOID FILLER | MQV | Substantially Equivalent | Ag Digital Technology Corp. | accessdata.fda.gov |
| April 4, 2008 | K072444 | WELLGRAFT PE I | MQV | Substantially Equivalent | Gwowei Technology Co., Ltd. | accessdata.fda.gov |
| April 4, 2008 | K072170 | WELLGRAFT PE II | MQV | Substantially Equivalent | Gwowei Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Filler, Bone Void, Calcium Compound
- All makers of Mixer, Cement, For Clinical Use
- All makers of Dispenser, Cement
Updated February 5, 2013. 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.