Treymed, Inc.
FDA Regulatory Profile
Treymed, Inc. has 0 FDA recalls, 6 inspections, 1 510(k) clearance and 1 compliance action on record.
- Latest inspection
- Aug 27, 2025 · VAI
- Latest 510(k)
- Jan 22, 2010
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 6 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Aug 27, 2025 | Sussex, WI | Devices | Voluntary Action Indicated (VAI) | 3003007937 |
| Sep 16, 2022 | Sussex, WI | Devices | No Action Indicated (NAI) | 3003007937 |
| Jul 12, 2017 | Sussex, WI | Devices | No Action Indicated (NAI) | 3003007937 |
| Aug 7, 2015 | Sussex, WI | Devices | Voluntary Action Indicated (VAI) | 3003007937 |
| Oct 21, 2014 | Sussex, WI | Devices | No Action Indicated (NAI) | 3003007937 |
| Oct 6, 2010 | Sussex, WI | Devices | Voluntary Action Indicated (VAI) | 3003007937 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3003007937 | Sussex, WI | 6 | Aug 27, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K093080 | METAPHOR METABOLIC MONITOR | Jan 22, 2010 |