Newmedical Technology, Inc.

FDA Regulatory Profile

Newmedical Technology, Inc. has 0 FDA recalls, 3 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 7, 2025 · NAI
Latest 510(k)
Oct 17, 2005

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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) clearances3Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 7, 2025Northbrook, ILDevicesNo Action Indicated (NAI)3005369309
Feb 5, 2014Northbrook, ILDevicesNo Action Indicated (NAI)3005369309
Jan 30, 2012Northbrook, ILDevicesNo Action Indicated (NAI)3005369309

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 3005369309Northbrook, IL3Aug 7, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K041704NEWGEL AND NEWGEL PLUS EOct 17, 2005
K040064NEWMEDICAL MICRO BONE DISTRACTOR/FIXATORMar 23, 2004
K030485NEWMEDICAL MICRO BONE DISTRACTOR/FIXATORDec 3, 2003

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