B. Braun Avitum AG

FDA Regulatory Profile

B. Braun Avitum AG has 0 FDA recalls, 5 inspections, 5 510(k) clearances and 0 compliance actions on record.

Latest inspection
Apr 23, 2026 · VAI
Latest 510(k)
Aug 11, 2017

Part of the B. Braun corporate family.

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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
Inspections5Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 23, 2026Melsungen, GermanyDevicesVoluntary Action Indicated (VAI)3002879653
Jun 18, 2015Melsungen, GermanyDevicesVoluntary Action Indicated (VAI)3002879653
Sep 29, 2011Glandorf, GermanyDevicesVoluntary Action Indicated (VAI)3004176176
Jun 17, 2011Melsungen, GermanyDevicesVoluntary Action Indicated (VAI)3002879653
Nov 19, 2009Glandorf, GermanyDevicesNo Action Indicated (NAI)3004176176

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
K170574Diacap Pro DialyzerAug 11, 2017
K143482xevonta dialyzerMar 1, 2016
K102194SOLCART BApr 25, 2011
K100334DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811Apr 22, 2010
K083460DIALOG WITH ADIMEA OPTIONFeb 18, 2010