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Cork Medical Products, LLC

FDA Regulatory Profile

Cork Medical Products, LLC has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Sep 15, 2015 · VAI
Latest 510(k)
Aug 13, 2021

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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
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 15, 2015Indianapolis, INDevicesVoluntary Action Indicated (VAI)3010588638

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
K203693Nisus Touch Negative Pressure Wound Therapy PumpAug 13, 2021
K140022NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML…Oct 24, 2014

FDA data resources