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Resoundant, Inc.

FDA Regulatory Profile

Resoundant, Inc. has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Apr 15, 2026 · NAI
Latest 510(k)
Jul 10, 2020

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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
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 15, 2026Rochester, MNDevicesNo Action Indicated (NAI)3013695852
Jul 20, 2022Rochester, MNDevicesNo Action Indicated (NAI)3013695852

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
K201389Resoundant Acoustic Driver SystemJul 10, 2020
K183193MREplus+ SoftwareAug 1, 2019

FDA data resources