Paragon Medical
Paragon Medical has 0 FDA recalls, 4 inspections, 5 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Jul 11, 2024 · NAI
- Latest 510(k)
- Jun 13, 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 | 5 | Oct 4, 2026 | Not stated | Current |
| Inspections | 4 | Oct 26, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 11, 2024 | Pierceton, IN | Devices | No Action Indicated (NAI) | 1000306340 |
| Sep 22, 2017 | Pierceton, IN | Devices | No Action Indicated (NAI) | 1000306340 |
| Aug 19, 2015 | Pierceton, IN | Devices | No Action Indicated (NAI) | 1000306340 |
| Jun 4, 2012 | Smithfield, UT | Devices | Voluntary Action Indicated (VAI) | 1000517406 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K190667 | Sonopet iQ Sterilization Tray | Jun 13, 2019 |
| K183701 | Stryker ChestShield Sterilization Tray System | May 7, 2019 |
| K173615 | Stryker Universal Select Sterilization Tray System | Apr 18, 2018 |
| K152951 | Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera… | Dec 28, 2015 |
| K032119 | PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS | Oct 29, 2003 |