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Avertix Medical, Inc.

FDA Regulatory Profile

Avertix Medical, Inc. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Mar 11, 2025 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 11, 2025Eatontown, NJDevicesOfficial Action Indicated (OAI)3017374019
Mar 28, 2022Eatontown, NJDevicesNo Action Indicated (NAI)3017374019

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.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3017374019Eatontown, NJ2Mar 11, 2025

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.