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Oratronics, Inc.

FDA Regulatory Profile

Oratronics, Inc. has 0 FDA recalls, 3 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Apr 16, 2014 · NAI
Latest 510(k)
Oct 9, 1979

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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
Inspections3Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 16, 2014New York, NYDevicesNo Action Indicated (NAI)2443020
Oct 7, 2011New York, NYDevicesNo Action Indicated (NAI)2443020
Sep 22, 2009New York, NYDevicesNo Action Indicated (NAI)2443020

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
K791366ORATRONICS ENDOSSEOUS FRAME ASSEMBLYOct 9, 1979

FDA data resources