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Bcg Medical, LLC

FDA Regulatory Profile

Bcg Medical, LLC has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Sep 13, 2018 · NAI
Latest 510(k)
Mar 17, 2017

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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
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 13, 2018Laguna Niguel, CADevicesNo Action Indicated (NAI)3009380895

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
K162562OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMYMar 17, 2017

FDA data resources