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 United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Nihon KohdenLabelled 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 15, 2026, FDA's public records list Nihon Kohden America with 166 510(k) clearances and 11 device recalls. The most recent is a device recall dated Sep 8, 2026: Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number:….
510(k) clearances: 166
Device recalls: 11
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
12017Records1
020182018Records0vs 2017−1
02019Records0vs 2018+0
020202020Records0vs 2019+0
22021Records2vs 2020+2
020222022Records0vs 2021−2
02023Records0vs 2022+0
420242024Records4vs 2023+4
02025Records0vs 2024−4
120262026 to dateRecords1
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
