Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in JapanLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Tomey Corporation and its 1 subsidiaries with 16 510(k) clearances. The most recent is a 510(k) clearance dated Dec 18, 2025: Tomey Optical Biometer OA-2000 (OA-2000).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Tomey Corporation and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 18, 2025 | Tomey Optical Biometer OA-2000 (OA-2000)K252348 · MXK | 510(k) clearances |
| Jul 18, 2025 | Tomey Cornea/Anterior Segment OCT (CASIA2)K250553 · OBO | 510(k) clearances |
| Apr 27, 2022 | Tomey Cornea/Anterior Segment OCT CASIA2K213265 · OBO | 510(k) clearances |
| Jan 19, 2018 | EM-4000 Specular MicroscopeK171313 · NQE | 510(k) clearances |
| Nov 18, 2008 | NON-CONTACT TONOMETER, MODEL FT-1000K073087 · HKX | 510(k) clearances |
| Apr 10, 2002 | UD-1000 ULTRASONIC A/B SCANNERK020151 · IYO | 510(k) clearances |
| Apr 8, 2002 | AL-2000 COMBINED BIOMETER AND PACHYMETERK012803 · IYO | 510(k) clearances |
| Aug 14, 1997 | CONFOSCANK971953 · HJO | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
