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Cablon Medical B.V.

FDA Regulatory Profile

Cablon Medical B.V. has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Feb 15, 2023 · VAI
Latest 510(k)
Mar 3, 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
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 15, 2023Leusden, NetherlandsDevicesVoluntary Action Indicated (VAI)3003062786
Jul 21, 2011Leusden, NetherlandsDevicesVoluntary Action Indicated (VAI)3003062786

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
K170058TheraView TBIMar 3, 2017

FDA data resources