Bontech, Inc.

FDA Regulatory Profile

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

Latest 510(k)
Sep 12, 2025

Reviewing Bontech, Inc. 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 Bontech, Inc.'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
Inspections0Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K243864BONX805Sep 12, 2025
K200787BSD3543WApr 23, 2020
K171485BSD4343R Digital Flat Panel X-ray DetectorJun 21, 2017
K162487BSD3543 Digital Flat Panel X-ray DetectorOct 14, 2016
K160204BSD4343 Digital Flat Panel X-ray DetectorJun 9, 2016