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 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Nikkiso and its 2 subsidiaries with 11 510(k) clearances, 2 warning letters and 1 device recall. The most recent is a warning letter dated Jul 23, 2025: Warning letter: Medical Devices.
Group recordsLabelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field.: 14, 3 entities
510(k) clearances: 11
Warning letters: 2
Device recalls: 1
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Nikkiso and its 2 subsidiaries
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
02017Records0
020182018Records0vs 2017+0
02019Records0vs 2018+0
020202020Records0vs 2019+0
12021Records1vs 2020+1
120222022Records1vs 2021+0
22023Records2vs 2022+1
020242024Records0vs 2023−2
42025Records4vs 2024+4
020262026 to dateRecords0
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
