Takagi Seiko Co., Ltd. FDA Record
- Latest inspection OAI · Apr 19, 2012
- No warning letters matched by name
Takagi Seiko Co., Ltd. has 0 FDA recalls, 1 inspection, 5 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Takagi Seiko Co., Ltd." is on file.
- Latest inspection
- Apr 19, 2012 · OAI
- Latest 510(k)
- Dec 10, 2018
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 | 5 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | 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 FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 19, 2012 | Nakano, Japan | Devices | Official Action Indicated (OAI) | 3001802794 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3001802794 | Nakano, Japan | 1 | Apr 19, 2012 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K182491 | Applanation tonometer AT-2 | Dec 10, 2018 |
| K172728 | Applanation tonometer AT-1 | Oct 17, 2017 |
| K162636 | Marco Ultra M3, Marco Ultra M4 | Apr 14, 2017 |
| K152535 | Z5 Slit lamp microscope, Z2 Slit lamp microscope | May 26, 2016 |
| K063352 | ELLEX SLIT LAMP, MODEL 30XL | Mar 13, 2007 |
Takagi Seiko Co., Ltd. and the FDA: common questions
Has Takagi Seiko Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Takagi Seiko 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 Takagi Seiko Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Takagi Seiko Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Takagi Seiko Co., Ltd.?
The most recent FDA inspection on file ended Apr 19, 2012 at Nakano, Japan and was classified OAI. FDA has 1 inspection of Takagi Seiko Co., Ltd. on file, 1 of them classified OAI (official action indicated).
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