Steelhead Surgical, Inc. FDA Record
Steelhead Surgical, Inc. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Steelhead Surgical, Inc." is on file.
- Latest inspection
- Mar 13, 2025 · 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 |
|---|---|---|---|---|
| Mar 13, 2025 | Medford, OR | Biologics | No Action Indicated (NAI) | 3019305349 |
- 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 3019305349 | Medford, OR | 1 | Mar 13, 2025 |
Steelhead Surgical, Inc. and the FDA: common questions
Has Steelhead Surgical, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Steelhead Surgical, Inc." 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 Steelhead Surgical, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Steelhead Surgical, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Steelhead Surgical, Inc.?
The most recent FDA inspection on file ended Mar 13, 2025 at Medford, OR and was classified NAI. FDA has 1 inspection of Steelhead Surgical, Inc. on file.
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