Hasomed GmbH

FDA Regulatory Profile

Hasomed GmbH has 0 FDA recalls, 3 inspections, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Sep 13, 2018 · VAI
Latest 510(k)
Feb 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) clearances4Oct 4, 2026Not statedCurrent
Inspections3Oct 27, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 13, 2018Magdeburg, GermanyDevicesVoluntary Action Indicated (VAI)3006141275
Jun 25, 2015Magdeburg, GermanyDevicesVoluntary Action Indicated (VAI)3006141275
Sep 25, 2012Magdeburg, GermanyDevicesNo Action Indicated (NAI)3006141275

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
K162683RehaStim 2Feb 3, 2017
K132416REHASTIM 2, ERIGOPRO (FES)May 28, 2014
K112844REHASTIM 2, REHAMOVE 2Oct 27, 2011
K073237REHASTIM & REHAMOVEDec 27, 2007