Saluda Medical Americas FDA Record
Saluda Medical Americas has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Saluda Medical Americas" is on file.
- Latest inspection
- Jan 15, 2026 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | 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 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 15, 2026 | Minneapolis, MN | Devices | No Action Indicated (NAI) | 3016111136 |
- 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 3016111136 | Minneapolis, MN | 1 | Jan 15, 2026 |
Saluda Medical Americas and the FDA: common questions
Has Saluda Medical Americas received an FDA warning letter?
No FDA warning letter addressed to the name "Saluda Medical Americas" 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 Saluda Medical Americas received an FDA Form 483?
FDA has not published a Form 483 for "Saluda Medical Americas" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Saluda Medical Americas?
The most recent FDA inspection on file ended Jan 15, 2026 at Minneapolis, MN and was classified NAI. FDA has 1 inspection of Saluda Medical Americas on file.
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