Holmed Corp. FDA Record
Holmed Corp. has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Holmed Corp." is on file.
- Latest inspection
- Jun 10, 2016 · NAI
- Latest 510(k)
- Aug 15, 1994
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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 | 2 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 10, 2016 | Attleboro, MA | Devices | No Action Indicated (NAI) | 1219518 |
- 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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1219518 | Attleboro, MA | 1 | Jun 10, 2016 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K942597 | CHRISTOUDIAS PERITONEUM TWIN TISSUE APPROXIMATOR | Aug 15, 1994 |
| K930330 | ENDOSCOPIC NEEDLEHOLDER, MODIFICATION | Jun 8, 1993 |
Holmed Corp. and the FDA: common questions
Has Holmed Corp. received an FDA warning letter?
No FDA warning letter addressed to the name "Holmed Corp." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Holmed Corp. received an FDA Form 483?
FDA has not published a Form 483 for "Holmed Corp." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Holmed Corp.?
The most recent FDA inspection on file ended Jun 10, 2016 at Attleboro, MA and was classified NAI. FDA has 1 inspection of Holmed Corp. on file.
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