Home / Companies / Koelis

Koelis

FDA Regulatory Profile

Koelis has 0 FDA recalls, 1 inspection, 7 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 3, 2015 · NAI
Latest 510(k)
Jul 10, 2018

Reviewing Koelis as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Request a free FDA snapshot

Or get Koelis's full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.

Get a free API key

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances7Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 3, 2015Meylan, FranceDevicesNo Action Indicated (NAI)3008487708

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
K180970Disposable guides KDNG00Jul 10, 2018
K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO…Jul 31, 2017
K170521TRINITY/3D PROSTATE SUITEMay 30, 2017
K160357TRINITYMay 2, 2016
K141334REUSABLE GUIDEJul 11, 2014
K1314483D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION…Jul 26, 2013
K100793UROSTATION 3D PROSTATE SUITESep 22, 2010

FDA data resources