Alber GmbH

FDA Regulatory Profile

Alber GmbH has 0 FDA recalls, 4 inspections, 5 510(k) clearances and 1 compliance action on record.

Latest inspection
Dec 15, 2022 · NAI
Latest 510(k)
May 24, 2022

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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) clearances5Oct 4, 2026Not statedCurrent
Inspections4Oct 25, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 15, 2022Albstadt, GermanyDevicesNo Action Indicated (NAI)3004730072
Apr 12, 2018Albstadt, GermanyDevicesNo Action Indicated (NAI)3004730072
May 11, 2017Albstadt, GermanyDevicesOfficial Action Indicated (OAI)3004730072
Aug 28, 2014Albstadt, GermanyDevicesVoluntary Action Indicated (VAI)3004730072

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
K221215e-motion M25May 24, 2022
K192618e-Motion M25Nov 2, 2020
K192016SMOOV O10May 19, 2020
K161241e-fix E35/E36Oct 5, 2016
K151717twionFeb 23, 2016