SETAGAYA SEIKI Co., Ltd. FDA Record
SETAGAYA SEIKI Co., Ltd. has 0 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "SETAGAYA SEIKI Co., Ltd." is on file.
- Latest 510(k)
- Sep 23, 2026
Summary
| 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 | 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 |
|---|---|---|
| K262144 | DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece | Sep 23, 2026 |
SETAGAYA SEIKI Co., Ltd. and the FDA: common questions
Has SETAGAYA SEIKI Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "SETAGAYA SEIKI Co., Ltd." 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 SETAGAYA SEIKI Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "SETAGAYA SEIKI Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
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