Bionix Corp.
Bionix Corp. has 0 FDA recalls, 6 inspections, 2 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Jul 14, 2026 · VAI
- Latest 510(k)
- Mar 20, 1986
Reviewing Bionix Corp. 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.
Or check Bionix Corp. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 2 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 6 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 14, 2026 | Maumee, OH | Devices | Voluntary Action Indicated (VAI) | 1526854 |
| Sep 2, 2022 | Maumee, OH | Devices | No Action Indicated (NAI) | 1526854 |
| Aug 24, 2017 | Maumee, OH | Devices | No Action Indicated (NAI) | 1526854 |
| Jun 23, 2016 | Maumee, OH | Devices | Voluntary Action Indicated (VAI) | 1526854 |
| Nov 21, 2013 | Maumee, OH | Devices | Voluntary Action Indicated (VAI) | 1526854 |
| Jun 17, 2010 | Maumee, OH | Devices | Voluntary Action Indicated (VAI) | 1526854 |
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1526854 | Maumee, OH | 6 | Jul 14, 2026 |