Lmt Medical Systems GmbH

FDA Regulatory Profile

Lmt Medical Systems GmbH has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 15, 2024 · NAI
Latest 510(k)
Jul 26, 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
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 15, 2024Lubeck, GermanyDevicesNo Action Indicated (NAI)3009514037
Jan 19, 2017Lubeck, GermanyDevicesVoluntary Action Indicated (VAI)3009514037

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
K171515NHAC 16Jul 26, 2017
K091047NEONATE ARRAY COILSAug 18, 2010