Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of HoribaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Horiba Instruments, Inc. with 28 device recalls and 5 510(k) clearances. The most recent is a device recall dated Mar 28, 2024: HORIBA custom configured fluorescence instrument, modular Fluorolog-QM.
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.
| Mar 28, 2024 | HORIBA custom configured fluorescence instrument, modular Fluorolog-QMClass II · HORIBA custom configured fluorescence instrument has a laser safety defect. This custom configuration of the modular In | Device recalls |
| Oct 30, 2018 | Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944Class II · Potential for chemical analyzer to report abnormal results due to an interference with triglycerides CP and Cholestero | Device recalls |
| Dec 4, 1985 | ELECTROLYTE ANALYZER SERA-252K853405 · CHL | 510(k) clearances |
| Sep 3, 1985 | SERA-210 ELECTROLYTE ANALYZERK853356 · CEM | 510(k) clearances |
| Jan 8, 1985 | MODIFY ELECTROLYTE ANALYZER MODEL SERA-210K844806 · CEM | 510(k) clearances |
| Jun 22, 1984 | ELECTROLYTE ANALYZER SERA-210K841424 · JGS | 510(k) clearances |
| Apr 6, 1984 | SERA-250K841441 · | 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
