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Nihon Kohden OrangeMed, LLC

United States·US-MF-000019023

Last updated September 17, 2026

Information

Country: United States
Address: 1800, E. Wilshire Avenue, Santa Ana, United States
Website: orange-med.com/
This website had an invalid or expired security certificate when we last checked. Last checked 2026-09-18.
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +19495026448
PRRC Contact: Sheryl Higgins
EUDAMED SRN: US-MF-000019023
FDA FEI Number: 3014631252
DUNS Number: —

Device	Model / Reference	Registries	Class	Status
Nihon Kohden	MSK3315P	FDA UDI	Class II	Active
Nihon Kohden	EXH3301P	FDA UDI	Class II	Active
Nihon Kohden	NKV-330	FDA UDI	Class II	Active
Nihon Kohden	DSP5500A	FDA UDI	Class II	Active
Nihon Kohden	NKV-550-U	FDA UDI	Class II	Active
Nihon Kohden	MSK3314P	FDA UDI	Class II	Active
Nihon Kohden	MSK3316P	FDA UDI	Class II	Active
Nihon Kohden	MSK3313P	FDA UDI	Class II	Active
Nihon Kohden NKV-550 Series Ventilator System	K192307	FDA 510(k)	Class II	Active
Nihon Kohden NKV-440 Ventilator System	K222644	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Nihon Kohden NKV-550 Series Ventilator System	K181695	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Nihon Kohden NKV-550 Series Ventilator System	K231778	FDA 510(k)	Class II	Active
Nihon Kohden NKV-330 Ventilator System	K213521	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 20, 2021	Z-2435-2021	—	terminated	Potential defective gas inlet pressure regulator within ventilator which could result in gas releasing noise from the bottom of the ventilator, a High Air/O2 Inlet Pressure alarm, a High/Low O2 alarm, or could not pass device Check prior to use.