Tricol Biomedical, Inc.

FDA Regulatory Profile

Tricol Biomedical, Inc. has 0 FDA recalls, 5 inspections, 1 510(k) clearance and 1 compliance action on record.

Latest inspection
Apr 2, 2018 · VAI
Latest 510(k)
Aug 29, 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
Inspections5Oct 25, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 2, 2018Portland, ORDevicesVoluntary Action Indicated (VAI)3004050854
Oct 31, 2014Portland, ORDevicesNo Action Indicated (NAI)3004050854
Dec 18, 2013Portland, ORDevicesNo Action Indicated (NAI)3004050854
Dec 11, 2009Portland, ORDevicesVoluntary Action Indicated (VAI)3004050854
Dec 2, 2009Portland, ORDevicesVoluntary Action Indicated (VAI)3004050854

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
K170958ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cmAug 29, 2017