Heraeus Medical Components, LLC

FDA Regulatory Profile

Heraeus Medical Components, LLC has 0 FDA recalls, 5 inspections, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 3, 2023 · VAI
Latest 510(k)
Dec 19, 2019

Updated: recalls Oct 23, 2026 · inspections Oct 23, 2026 · compliance actions Oct 23, 2026.

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Summary

Recalls
0
510(k) Clearances
4
Inspections
5
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 3, 2023Cartago, Costa RicaDevicesVoluntary Action Indicated (VAI)3013666336
Oct 5, 2016Plymouth, MNDevicesNo Action Indicated (NAI)3003631559
Jul 14, 2016San Rafael, Costa RicaDevicesNo Action Indicated (NAI)3010352063
Jul 2, 2013Plymouth, MNDevicesVoluntary Action Indicated (VAI)3003631559
Aug 25, 2010Plymouth, MNDevicesNo Action Indicated (NAI)3003631559

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
K191305Hereaeus Poseidon MicrocatheterDec 19, 2019
K191502Heraeus Peripheral GuidewireNov 26, 2019
K170664Odyssey Micro CatheterNov 9, 2017
K173052Heraeus TMW GuidewireOct 20, 2017