A.M. Surgical, Inc.
A.M. Surgical, Inc. has 0 FDA recalls, 7 inspections, 6 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Oct 20, 2023 · NAI
- Latest 510(k)
- Oct 16, 2019
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 6 | Oct 4, 2026 | Not stated | Current |
| Inspections | 7 | Oct 25, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Oct 20, 2023 | Nashua, NH | Devices | No Action Indicated (NAI) | 3001617730 |
| Jul 27, 2021 | Nashua, NH | Devices | Voluntary Action Indicated (VAI) | 3001617730 |
| Jul 6, 2018 | Nashua, NH | Devices | Voluntary Action Indicated (VAI) | 3001617730 |
| Apr 16, 2015 | Nashua, NH | Devices | No Action Indicated (NAI) | 3001617730 |
| Dec 11, 2012 | Nashua, NH | Devices | No Action Indicated (NAI) | 3001617730 |
| Oct 15, 2010 | Nashua, NH | Devices | No Action Indicated (NAI) | 3001617730 |
| Oct 22, 2008 | Nashua, NH | Devices | Voluntary Action Indicated (VAI) | 3001617730 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K191771 | SECURE Screw | Oct 16, 2019 |
| K191345 | Pegasus System | Jul 17, 2019 |
| K180087 | A.M. Surgical Intramedullary Fixation Device | May 18, 2018 |
| K080133 | MOUNTABLE ENDOSCOPIC BLADE | Mar 13, 2008 |
| K042458 | A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM | Oct 7, 2004 |
| K982142 | MOUNTABLE ENDOSCOPIC KNIFE | Dec 30, 1998 |