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.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Nidek Co., Ltd. and its 2 subsidiaries with 115 510(k) clearances and 30 device recalls. The most recent is a 510(k) clearance dated Mar 30, 2023: Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-E….
Group recordsLabelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field.: 145, 3 entities
510(k) clearances: 115
Device recalls: 30
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Nidek Co., Ltd. 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.
32017Records3
420182018Records4vs 2017+1
22019Records2vs 2018−2
320202020Records3vs 2019+1
02021Records0vs 2020−3
020222022Records0vs 2021+0
12023Records1vs 2022+1
020242024Records0vs 2023−1
02025Records0vs 2024+0
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
