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Elevate Surgical Co

FDA Regulatory Profile

Elevate Surgical Co has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 23, 2025 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections5Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 23, 2025Honolulu, HIBiologicsNo Action Indicated (NAI)3010007795
Jul 27, 2023San Diego, CABiologicsNo Action Indicated (NAI)3012346493
Mar 4, 2019Honolulu, HIBiologicsVoluntary Action Indicated (VAI)3010007795
Aug 1, 2018San Diego, CABiologicsNo Action Indicated (NAI)3012346493
Nov 6, 2014Honolulu, HIBiologicsNo Action Indicated (NAI)3010007795

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.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3010007795Honolulu, HI3Jul 23, 2025
FEI 3012346493San Diego, CA2Jul 27, 2023

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.