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 Neitz Instruments Company Ltd. with 24 510(k) clearances and 2 warning letters. The most recent is a warning letter dated Oct 2, 2023: Warning letter: Medical Devices.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Oct 2, 2023 | Warning letter: Medical DevicesCDRH | Warning letters |
| Aug 25, 2023 | Warning letter: Complaint handling, MDR reportingCDRH | Warning letters |
| Sep 30, 1997 | CATARACTSCREENER CT - SK972440 · HKI | 510(k) clearances |
| Jun 15, 1995 | NEITZ SLIT LAMP SL-H2K951341 · HJO | 510(k) clearances |
| Jun 8, 1995 | FIBER HEAD LIGHT FH-300K951337 · HPQ | 510(k) clearances |
| May 3, 1995 | OTOSCOPE A-34K950788 · ERA | 510(k) clearances |
| Apr 10, 1995 | NEITZ SLIT LAMP SL-H1K951340 · HJO | 510(k) clearances |
| Apr 7, 1995 | INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TVK951338 · HLI | 510(k) clearances |
| Mar 28, 1995 | SPOT RETINOSCOPE RX-3SPK950793 · HKM | 510(k) clearances |
| Mar 28, 1995 | STREAK RETINOSCOPE RX-RPK950795 · HKM | 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
