Axcan Scientific Corp. FDA Record
Axcan Scientific Corp. has 0 FDA recalls, 0 inspections, 5 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Axcan Scientific Corp." is on file.
- Latest 510(k)
- Sep 21, 1984
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 5 | 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 |
|---|---|---|
| K842943 | AXCAN UTERINE SUCCION INJECTOR | Sep 21, 1984 |
| K831212 | ENDOSCANN | Jun 15, 1984 |
| K831224 | AUGROS HYSTEROMETER | Oct 28, 1983 |
| K831669 | AXCAN SPERM CUP | Jul 12, 1983 |
| K820641 | ACCURETTE | Jun 22, 1982 |
Axcan Scientific Corp. and the FDA: common questions
Has Axcan Scientific Corp. received an FDA warning letter?
No FDA warning letter addressed to the name "Axcan Scientific Corp." 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 Axcan Scientific Corp. received an FDA Form 483?
FDA has not published a Form 483 for "Axcan Scientific Corp." in its reading room. FDA publishes some Form 483s, not all of them.
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