Data / Medical devices / United States / Nexera Medical LLC
Nexera Medical LLC: FDA-registered device maker in Surfside, FL, United States, 3 510(k) clearances
Nexera Medical LLC is registered with the FDA (registration 3037969189) in Surfside, FL, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated December 29, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3037969189
- Address
- 9429 Harding Avenue # 293, Surfside, FL, United States, 33154
- Owner or operator
- Nexera Medical LLC (10093260)
- Roles
- Manufacturer
- First device listed
- April 21, 2025
- Registered through
- 2026
- Brand names listed
- N95 respirator with antimicrobial/antiviral agent, SpectraShield
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| N95 Respirator With Antimicrobial/Antiviral Agent | ONT | 2 | 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 |
|---|---|---|---|---|---|---|
| December 29, 2015 | K150729 | SpectraShield 9500 Surgical N95 Respirator | ONT | Substantially Equivalent | Nexera Medical, Inc. | accessdata.fda.gov |
| July 5, 2012 | K120244 | SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR | ONT | Substantially Equivalent | Nexera Medical, Inc. | accessdata.fda.gov |
| February 24, 2011 | K090414 | SPECTRASHIELD 9500 SURGICAL MASK | ONT | Substantially Equivalent | Nexera Medical, Inc. | accessdata.fda.gov |
Updated December 29, 2015. 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.