Huestis Machine Corporation
Huestis Machine Corporation has 0 FDA recalls, 5 inspections, 7 510(k) clearances and 1 compliance action on record.
- Latest inspection
- Jun 30, 2022 · VAI
- Latest 510(k)
- Sep 14, 2018
Reviewing Huestis Machine Corporation 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 get Huestis Machine Corporation's full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 7 | Oct 4, 2026 | Not stated | Current |
| Inspections | 5 | Oct 25, 2026 | Not stated | Current |
| Compliance actions | 1 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 30, 2022 | Bristol, RI | Devices | Voluntary Action Indicated (VAI) | 1219183 |
| Sep 15, 2017 | Bristol, RI | Devices | Voluntary Action Indicated (VAI) | 1219183 |
| Mar 27, 2014 | Bristol, RI | Devices | Voluntary Action Indicated (VAI) | 1219183 |
| May 13, 2013 | Bristol, RI | Devices | Voluntary Action Indicated (VAI) | 1219183 |
| Jun 24, 2011 | Bristol, RI | Devices | Voluntary Action Indicated (VAI) | 1219183 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K181874 | MX40 Mobile Digital X-ray System | Sep 14, 2018 |
| K940145 | COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICE | Jan 24, 1995 |
| K926187 | POSICAST IMMOBILIZATION SYSTEM | Apr 15, 1994 |
| K904005 | HUESTIS FLEXI-BOARD | Nov 29, 1990 |
| K901567 | THE HUESTIS COMPU-PLOTTER | May 31, 1990 |
| K880047 | HUESTIS COMPU-FORMER | Apr 11, 1988 |
| K792721 | HUESTIS FLEXI-HOLDER | Feb 19, 1980 |