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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

DeviceProduct codeClassRoleSource
Splint, Intranasal SeptalLYA1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 22, 2023K230142Epi-Stop Nasal Gel/epistaxis packLYASubstantially EquivalentBiomed 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.