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Operating Room Innovations, Inc.

FDA Regulatory Profile

Operating Room Innovations, Inc. has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
May 22, 2025 · OAI
Latest 510(k)
Aug 5, 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) clearances1Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 22, 2025La Jolla, CADevicesOfficial Action Indicated (OAI)3017838287
Apr 13, 2023La Jolla, CADevicesNo Action Indicated (NAI)3017838287

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
K200977Modular TogaAug 5, 2020

FDA data resources