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Anexa Biomedical, Inc.

FDA Regulatory Profile

Anexa Biomedical, Inc. has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 10, 2026 · VAI
Latest 510(k)
Sep 21, 2017

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances2Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 10, 2026North Richland Hills, TXDevicesVoluntary Action Indicated (VAI)3027590916

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K172486Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL…Sep 21, 2017
K161658Anexa Wound Flush, Sterile Water & Sterile Normal SalineSep 14, 2016

FDA data resources