Ion Medical, LLC
FDA Regulatory Profile
Ion Medical, LLC has 0 FDA recalls, 4 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest inspection
- Jun 13, 2025 · NAI
- Latest 510(k)
- Dec 13, 2007
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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 8, 2026 | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 4 | Nov 11, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
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 3006747129 | Jacksonville, FL | 4 | Jun 13, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K072911 | ION MEDICAL BIPOLAR COAGULATION PEN | Dec 13, 2007 |