Herniamesh
Herniamesh has 0 FDA recalls, 4 inspections, 4 510(k) clearances and 1 compliance action on record.
- Latest inspection
- Nov 21, 2024 · VAI
- Latest 510(k)
- Jun 19, 2008
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 4 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 4 | Nov 13, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 21, 2024 | Chivasso, Italy | Devices | Voluntary Action Indicated (VAI) | 3005404334 |
| Jul 1, 2016 | Chivasso, Italy | Devices | No Action Indicated (NAI) | 3005404334 |
| Jul 23, 2015 | Chivasso, Italy | Devices | Official Action Indicated (OAI) | 3005404334 |
| Nov 5, 2009 | Chivasso, Italy | Devices | Voluntary Action Indicated (VAI) | 3005404334 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Herniamesh: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3005404334 | Chivasso, Italy | 4 | Nov 21, 2024 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K081327 | RELIMESH | Jun 19, 2008 |
| K050516 | T-SLING | Feb 3, 2006 |
| K020652 | HERNIAMESH T-SLING | May 15, 2002 |
| K973955 | HERNIAMESH SURGICAL MESHES | May 11, 1998 |
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