NIHON KOHDEN ORANGEMED, INC
FDA Regulatory Profile
NIHON KOHDEN ORANGEMED, INC appears in FDA public data with 1 recall, 5 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2435-2021, Class II) was initiated on July 20, 2021. Its most recent 510(k) clearance was granted on March 1, 2024.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2435-2021 | Class II | Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden | July 20, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K231778 | Nihon Kohden NKV-550 Series Ventilator System | March 1, 2024 |
| K222644 | Nihon Kohden NKV-440 Ventilator System | May 31, 2023 |
| K213521 | Nihon Kohden NKV-330 Ventilator System | July 1, 2022 |
| K192307 | Nihon Kohden NKV-550 Series Ventilator System | January 10, 2020 |
| K181695 | Nihon Kohden NKV-550 Series Ventilator System | December 7, 2018 |