Sun Medical, Inc.
Sun Medical, Inc. has 0 FDA recalls, 3 inspections, 6 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Feb 26, 2020 · NAI
- Latest 510(k)
- May 27, 2015
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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 | 6 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | Nov 13, 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 |
|---|---|---|---|---|
| Feb 26, 2020 | Quinlan, TX | Devices | No Action Indicated (NAI) | 1627662 |
| Apr 7, 2016 | Quinlan, TX | Devices | No Action Indicated (NAI) | 1627662 |
| Mar 12, 2012 | Quinlan, TX | Devices | No Action Indicated (NAI) | 1627662 |
- 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 1627662 | Quinlan, TX | 3 | Feb 26, 2020 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K150511 | Coating Material | May 27, 2015 |
| K143265 | Acrylic Block | Apr 14, 2015 |
| K921963 | DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900 | Sep 11, 1992 |
| K911154 | SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200 | Jul 26, 1991 |
| K874948 | SUN MEDICAL SMOKE EVACUATOR SYSTEM | Feb 18, 1988 |
| K845006 | SUN MEDICAL LAMINARIA CERVICAL DILATOR | May 1, 1985 |
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