Alliance Tech Medical, Inc
FDA Regulatory Profile
Alliance Tech Medical, Inc has 1 FDA recall, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest recall
- Z-0714-2020 · Class II · Oct 6, 2014
- Latest inspection
- Aug 20, 2025 · VAI
- Latest 510(k)
- Dec 13, 2004
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 1 | 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 | 2 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0714-2020 | Class II | Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters individually packaged… | Oct 6, 2014 |
Recent FDA Inspections
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 3004476631 | Granbury, TX | 2 | Aug 20, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K043148 | ALL FLOW PULMONARY FUNCTION FILTER | Dec 13, 2004 |