Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
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 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Nihon Kohden and its 3 subsidiaries with 204 510(k) clearances, 12 device recalls and 1 warning letter. The most recent is a 510(k) clearance dated Aug 12, 2026: GF-310R Multigas Unit (GF-310R).
Group recordsLabelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field.: 217, 4 entities
510(k) clearances: 204
Device recalls: 12
Warning letters: 1
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Nihon Kohden and its 3 subsidiaries
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
62017Records6
120182018Records1vs 2017−5
22019Records2vs 2018+1
220202020Records2vs 2019+0
62021Records6vs 2020+4
320222022Records3vs 2021−3
22023Records2vs 2022−1
520242024Records5vs 2023+3
32025Records3vs 2024−2
420262026 to dateRecords4
Latest Records
Newest first across sources; each opens the record
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
