Truemed Group, LLC

FDA Regulatory Profile

Truemed Group, LLC has 0 FDA recalls, 3 inspections, 5 510(k) clearances and 0 compliance actions on record.

Latest inspection
Apr 28, 2025 · VAI
Latest 510(k)
Jul 9, 2021

Reviewing Truemed Group, LLC as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Request a free FDA snapshot

Or get Truemed Group, LLC's full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.

Get a free API key

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances5Oct 4, 2026Not statedCurrent
Inspections3Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 28, 2025The Woodlands, TXDevicesVoluntary Action Indicated (VAI)3010393000
Jun 5, 2019The Woodlands, TXDevicesVoluntary Action Indicated (VAI)3010393000
Sep 11, 2015The Woodlands, TXDevicesNo Action Indicated (NAI)3010393000

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
K200575TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEMJul 9, 2021
K182650Arzzt Distal Radius and Ulna SystemJun 10, 2019
K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden…Jan 16, 2018
K162507Arzzt 3.5 / 4.5 Small & Large Fragments SystemAug 3, 2017
K133166INS HILDEN TIBIAL ARZZTNov 6, 2014