Biotrace Medical, Inc.
Biotrace Medical, Inc. has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record.
- Latest inspection
- Jun 24, 2019 · NAI
- Latest 510(k)
- Oct 25, 2016
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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 | 1 | 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 24, 2019 | Menlo Park, CA | Devices | No Action Indicated (NAI) | 3013472601 |
- 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 3013472601 | Menlo Park, CA | 1 | Jun 24, 2019 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K160260 | Tempo Temporary Pacing Lead | Oct 25, 2016 |
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