Mali, Inc. FDA Record
Mali, Inc. has 0 FDA recalls, 0 inspections, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Mali, Inc." is on file.
- Latest 510(k)
- Nov 4, 1986
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 2 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 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 |
|---|---|---|
| K864176 | GENTLE FEEL | Nov 4, 1986 |
| K855209 | NIR LAT MALE EXTERNAL CATHETER | Jan 10, 1986 |
Mali, Inc. and the FDA: common questions
Has Mali, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Mali, Inc." 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 Mali, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Mali, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
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