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Vomaris Wound Care, Inc.

FDA Regulatory Profile

Vomaris Wound Care, Inc. has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Jun 7, 2018 · NAI
Latest 510(k)
Dec 10, 2018

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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) clearances1Oct 4, 2026Not statedCurrent
Inspections2Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 7, 2018Fountain Hills, AZDevicesNo Action Indicated (NAI)3005803853
May 5, 2011Fountain Hills, AZDevicesNo Action Indicated (NAI)3005803853

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
K180533Procellera Composite Antibacterial Wound DressingDec 10, 2018

FDA data resources