Belimed AG

FDA Regulatory Profile

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

Latest inspection
Jun 21, 2019 · VAI
Latest 510(k)
Oct 31, 2019

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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) clearances3Oct 4, 2026Not statedCurrent
Inspections4Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 21, 2019Grosuplje, SloveniaDevicesVoluntary Action Indicated (VAI)3010653034
Jun 19, 2019Zug, SwitzerlandDevicesNo Action Indicated (NAI)3001061128
Apr 16, 2015Sulgen, SwitzerlandDevicesNo Action Indicated (NAI)3003927243
Aug 10, 2012Sulgen, SwitzerlandDevicesNo Action Indicated (NAI)3003927243

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
K191896Belimed Steam Sterilizer MST-H TOP 5000Oct 31, 2019
K170228Belimed Steam Sterilizer MST-H TOP 5000May 12, 2017
K130172BELIMED STEAM STERILIZER MST-VSep 23, 2013