Hamilton Thorne, Inc.
Hamilton Thorne, Inc. has 0 FDA recalls, 5 inspections, 6 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Nov 9, 2023 · NAI
- Latest 510(k)
- Jul 2, 2021
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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 | 5 | Oct 25, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 9, 2023 | Beverly, MA | Devices | No Action Indicated (NAI) | 1221433 |
| Aug 9, 2018 | Beverly, MA | Devices | Voluntary Action Indicated (VAI) | 1221433 |
| Aug 3, 2016 | Beverly, MA | Devices | No Action Indicated (NAI) | 1221433 |
| Jan 10, 2013 | Beverly, MA | Devices | Voluntary Action Indicated (VAI) | 1221433 |
| Jun 9, 2010 | Beverly, MA | Devices | No Action Indicated (NAI) | 1221433 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K202241 | LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) | Jul 2, 2021 |
| K192503 | GM501 Wash with Phenol Red and Gentamicin | Nov 19, 2020 |
| K192644 | GM501 SpermAir and GM501 SpermActive | Apr 23, 2020 |
| K191552 | GM501 Mineral Oil | Sep 18, 2019 |
| K190383 | GM501 Wash | Sep 5, 2019 |
| K120055 | HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL… | Apr 24, 2012 |