Tomey Corporation FDA Record
Tomey Corporation has 0 FDA recalls, 1 inspection, 6 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Tomey Corporation" is on file.
- Latest inspection
- Feb 9, 2017 · NAI
- Latest 510(k)
- Dec 18, 2025
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 6 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | 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 FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 9, 2017 | Nagoya, Japan | Devices | No Action Indicated (NAI) | 3002680900 |
- 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 3002680900 | Nagoya, Japan | 1 | Feb 9, 2017 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K252348 | Tomey Optical Biometer OA-2000 (OA-2000) | Dec 18, 2025 |
| K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2) | Jul 18, 2025 |
| K213265 | Tomey Cornea/Anterior Segment OCT CASIA2 | Apr 27, 2022 |
| K171313 | EM-4000 Specular Microscope | Jan 19, 2018 |
| K073087 | NON-CONTACT TONOMETER, MODEL FT-1000 | Nov 18, 2008 |
| K012803 | AL-2000 COMBINED BIOMETER AND PACHYMETER | Apr 8, 2002 |
Tomey Corporation and the FDA: common questions
Has Tomey Corporation received an FDA warning letter?
No FDA warning letter addressed to the name "Tomey Corporation" 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 Tomey Corporation received an FDA Form 483?
FDA has not published a Form 483 for "Tomey Corporation" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Tomey Corporation?
The most recent FDA inspection on file ended Feb 9, 2017 at Nagoya, Japan and was classified NAI. FDA has 1 inspection of Tomey Corporation on file.
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