Data / Medical devices / Brazil / Fabinject Industria E Comercio Importacao E Exportacao Ltda
Fabinject Industria E Comercio Importacao E Exportacao Ltda: FDA-registered device maker in Taubate Sao Paulo, Brazil, 1 510(k) clearance
Fabinject Industria E Comercio Importacao E Exportacao Ltda is registered with the FDA (registration 3006427656) in Taubate Sao Paulo, Brazil. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 18, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006427656
- Address
- Rua Engenheiro Joao Porfirio de Macedo 401, Taubate Sao Paulo, Brazil, 12072-270
- Owner or operator
- Fabinject Industria e Comercio Importacao e Exportacao Ltda (10090582)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 17, 2024
- Registered through
- 2026
- Brand names listed
- B 15G-100, B 15G-110, B 15G-30, B 15G-50, B 15G-70, B 15G-80, B 16G-100, B 16G-110 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | OTN | 2 | Contract manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Transilluminator, Battery-Powered | HJN | 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 |
|---|---|---|---|---|---|---|
| October 18, 2024 | K242132 | FREDDO | GEX | Substantially Equivalent | Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Transilluminator, Battery-Powered
- All makers of Pack, Hot Or Cold, Reusable
- All makers of Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- All makers of Cannula, Surgical, General & Plastic Surgery
Updated October 18, 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.