Data / Medical devices / Brazil / Magnamed Tecnologia Medica S/A
Magnamed Tecnologia Medica S/A: FDA-registered device maker in Sao Paulo, Brazil, 1 510(k) clearance
Magnamed Tecnologia Medica S/A is registered with the FDA (registration 3024290085) in Sao Paulo, Brazil. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 24, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024290085
- Address
- Rua Maquerobi, 140 Rua Maquerobi, 140, Sao Paulo, Brazil, 04053-030
- Owner or operator
- Magnamed Tecnologia Medica S/A (10088212)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- June 9, 2023
- Registered through
- 2026
- Brand names listed
- ADUL/PED SINGLE USE ACCESSORY KIT FOR OXYMAG, KIT DISPOSABLE RESPIRATORY CIRCUIT, Oxymag
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Specification developer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Specification developer | accessdata.fda.gov |
| Ventilator, Emergency, Powered (Resuscitator) | BTL | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| May 24, 2023 | K221634 | Oxymag - Transport and Emergency Ventilator | BTL | Substantially Equivalent | Magnamed Tecnologia Medica S/A | accessdata.fda.gov |
Compare with other makers
- All makers of Tubing, Pressure And Accessories
- All makers of Ventilator, Emergency, Powered (Resuscitator)
- All makers of Set, Tubing And Support, Ventilator (W Harness)
Updated May 24, 2023. 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.