Equipmed USA, LLC FDA Record
- No warning letters matched by name
Equipmed USA, LLC has 0 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Equipmed USA, LLC" is on file.
- Latest 510(k)
- Dec 20, 2022
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 1 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 0 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K221070 | DP4 Microneedling device | Dec 20, 2022 |
Equipmed USA, LLC and the FDA: common questions
Has Equipmed USA, LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Equipmed USA, LLC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Equipmed USA, LLC received an FDA Form 483?
FDA has not published a Form 483 for "Equipmed USA, LLC" in its reading room. FDA publishes some Form 483s, not all of them.
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