Diagnostics 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 its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list HORIBA and its 3 subsidiaries with 54 510(k) clearances and 28 device recalls. The most recent is a 510(k) clearance dated Sep 14, 2026: Yumizen H550.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, HORIBA and its 3 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 14, 2026 | Yumizen H550K260781 · GKZ | 510(k) clearances |
| May 21, 2024 | Yumizen H2500K232946 · GKZ | 510(k) clearances |
| 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 |
| May 10, 2021 | Yumizen C1200 Creatinine PAPK193649 · JFY | 510(k) clearances |
| Jun 26, 2020 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MK193525 · CZP | 510(k) clearances |
| Jun 25, 2020 | Yumizen C1200 CRPK192028 · DCK | 510(k) clearances |
| Mar 6, 2020 | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorK191562 · DBF | 510(k) clearances |
| Oct 3, 2019 | Yumizen C1200 CRPK191993 · DCK | 510(k) clearances |
| Aug 30, 2019 | Yumizen C1200 ALP, Yumizen C1200 AlbuminK191245 · CJE | 510(k) clearances |
| 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 |
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
