Data / Medical devices / United States / Anexa Biomedical, Inc.
Anexa Biomedical, Inc.: FDA-registered device maker in North Richland Hills, TX, United States, 2 510(k) clearances
Anexa Biomedical, Inc. is registered with the FDA (registration 3027590916) in North Richland Hills, TX, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 21, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027590916
- Address
- 7201 Iron Horse Blvd. --, North Richland Hills, TX, United States, 76180
- Owner or operator
- PRESTIGE AMERITECH (9070341)
- Roles
- Manufacturer
- First device listed
- July 11, 2023
- Registered through
- 2026
- Brand names listed
- Anexa Biomedical, Inc.
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | 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 |
|---|---|---|---|---|---|---|
| September 21, 2017 | K172486 | Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle | FRO | Substantially Equivalent | Anexa Biomedical, Inc. | accessdata.fda.gov |
| September 14, 2016 | K161658 | Anexa Wound Flush, Sterile Water & Sterile Normal Saline | FRO | Substantially Equivalent | Anexa Biomedical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 21, 2017. 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.