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 Orangemed with 5 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Mar 1, 2024: Nihon Kohden NKV-550 Series Ventilator System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 1, 2024 | Nihon Kohden NKV-550 Series Ventilator SystemK231778 · CBK | 510(k) clearances |
| May 31, 2023 | Nihon Kohden NKV-440 Ventilator SystemK222644 · CBK | 510(k) clearances |
| Jul 1, 2022 | Nihon Kohden NKV-330 Ventilator SystemK213521 · MNT | 510(k) clearances |
| Jul 20, 2021 | Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is intClass II · Potential defective gas inlet pressure regulator within ventilator which could result in gas releasing noise from the b | Device recalls |
| Jan 10, 2020 | Nihon Kohden NKV-550 Series Ventilator SystemK192307 · CBK | 510(k) clearances |
| Dec 7, 2018 | Nihon Kohden NKV-550 Series Ventilator SystemK181695 · CBK | 510(k) clearances |
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
