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Merete GmbH

FDA Regulatory Profile

Merete GmbH has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 1 compliance action on record.

Latest inspection
May 5, 2022 · NAI
Latest 510(k)
Oct 17, 2018

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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
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 5, 2022Berlin, GermanyDevicesNo Action Indicated (NAI)3002949614
Jul 2, 2009Berlin, GermanyDevicesVoluntary Action Indicated (VAI)3002949614

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
K181026OsteoBridge™ IDSF SystemOct 17, 2018
K172213MECRON Cannulated Screw SystemOct 23, 2017

FDA data resources