Home / Companies / Dio Medical Co., Ltd.

Dio Medical Co., Ltd.

FDA Regulatory Profile

Dio Medical Co., Ltd. has 0 FDA recalls, 0 inspections, 13 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Mar 9, 2023

Reviewing Dio Medical Co., Ltd. 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 Dio Medical Co., Ltd.'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) clearances13Oct 4, 2026Not statedCurrent
Inspections0Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K223790Huvex Interspinous Fusion SystemMar 9, 2023
K223140AEON-C™ Stand Alone SystemDec 20, 2022
K222415Rexious Spinal Fixation SystemOct 25, 2022
K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ &…Oct 18, 2022
K222448UNITY Sacroiliac Joint Fixation SystemOct 13, 2022
K222515FaSet Fixation SystemOct 5, 2022
K162849Huvex Interspinous Fixation SystemFeb 16, 2017
K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageNov 21, 2016
K122872INTERVERTEBRAL BODY FUSION DEVICEFeb 28, 2013
K121862REX ANTERIOR CERVICAL PLATE SYSTEMOct 31, 2012
K113324REXIOUS HOOK FIXATION SYSTEMSMar 28, 2012
K111362REXIOUS SPINAL FIXATION SYSTEMJul 21, 2011
K100765FIXPINE II SYSTEMJul 19, 2010

FDA data resources