Data / Medical devices / United States / Biomed Ent, Inc
Biomed Ent, Inc: FDA-registered device maker in Milwaukee, WI, United States, 1 510(k) clearance
Biomed Ent, Inc is registered with the FDA (registration 3015174190) in Milwaukee, WI, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 22, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015174190
- Address
- 757 N Water St Ste 300, Milwaukee, WI, United States, 53202
- Owner or operator
- BioMed ENT, Inc (10084500)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- November 29, 2023
- Registered through
- 2026
- Brand names listed
- Epi-Stop Nasal Gel
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Splint, Intranasal Septal | LYA | 1 | Complaint file establishment, Repackager or relabeler, 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 |
|---|---|---|---|---|---|---|
| March 22, 2023 | K230142 | Epi-Stop Nasal Gel/epistaxis pack | LYA | Substantially Equivalent | Biomed Ent, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 22, 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.