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Colorado Therapeutics, LLC

FDA Regulatory Profile

Colorado Therapeutics, LLC has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 21, 2019 · NAI
Latest 510(k)
Oct 25, 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) clearances2Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 21, 2019Louisville, CODevicesNo Action Indicated (NAI)3012547639

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
K172937Colorado Therapeutics Xenograft ImplantOct 25, 2017
K160181COLORADO THERAPEUTICS XENOGRAFT IMPLANTOct 20, 2016

FDA data resources