Imed Technology, Inc.

FDA Regulatory Profile

Imed Technology, Inc. has 0 FDA recalls, 5 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 6, 2025 · NAI
Latest 510(k)
May 28, 2015

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances2Nov 8, 2026File dated Nov 2, 2026Current
Inspections5Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 6, 2025Mckinney, TXDevicesNo Action Indicated (NAI)3003813437
Oct 18, 2022Mckinney, TXDevicesVoluntary Action Indicated (VAI)3003813437
Jun 16, 2017Mckinney, TXDevicesVoluntary Action Indicated (VAI)3003813437
Jan 30, 2013Mckinney, TXDevicesNo Action Indicated (NAI)3003813437
Dec 8, 2011Mckinney, TXDevicesOfficial Action Indicated (OAI)3003813437

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.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3003813437Mckinney, TX5Aug 6, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K150513Imed Technology Intravascular Administration Set, Imed Technology Extension SetMay 28, 2015
K102712MED GRAVITY SET, IMED PUMP SETDec 16, 2011

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.