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Curbell Medical Products, Inc.

FDA Regulatory Profile

Curbell Medical Products, Inc. has 0 FDA recalls, 3 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Mar 27, 2017 · VAI
Latest 510(k)
Nov 7, 2018

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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) clearances1Oct 4, 2026Not statedCurrent
Inspections3Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 27, 2017Orchard Park, NYDevicesVoluntary Action Indicated (VAI)3000210521
Oct 9, 2014Orchard Park, NYDevicesNo Action Indicated (NAI)3000210521
Apr 9, 2012Orchard Park, NYDevicesNo Action Indicated (NAI)3000210521

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
K182220Curbell branded Patient Monitoring CablesNov 7, 2018

FDA data resources