Owens & Minor Halyard, Inc.

FDA Regulatory Profile

Owens & Minor Halyard, Inc. has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Oct 12, 2017 · NAI
Latest 510(k)
Mar 22, 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) clearances2Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
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Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 12, 2017Southaven, MSFood/CosmeticsNo Action Indicated (NAI)3004343748
Jan 23, 2013Southaven, MSFood/CosmeticsNo Action Indicated (NAI)3004343748

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
K181959HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)Mar 22, 2019
K182096Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy DrugsNov 2, 2018