Nihon Kohden Orangemed Inc

FDA Filings

This page includes the latest FDA filings for Nihon Kohden Orangemed Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3014631252
• FEI Number: 3014631252
• Name: NIHON KOHDEN ORANGEMED, INC.
• Owner & Operator: Nihon Kohden OrangeMed, Inc.
• Contact Address: 1800 E. Wilshire Avenue ; Santa Ana CA 92705 US
• Official Correspondent:
  • Sheryl Higgins
  • 1-949-5026448-7012
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1800 E. Wilshire Avenue ; Santa Ana, CA 92705 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00843685100166 NIHON KOHDEN ORANGEMED, INC.	Nihon Kohden	2023-06-13
GUDID 00843685100159 NIHON KOHDEN ORANGEMED, INC.	Nihon Kohden	2023-06-13
GUDID 20843685100078 NIHON KOHDEN ORANGEMED, INC.	Nihon Kohden MSK3315P	2022-10-19
GUDID 10843685100170 NIHON KOHDEN ORANGEMED, INC.	Nihon Kohden MSK3316P	2022-10-19
GUDID 10843685100064 NIHON KOHDEN ORANGEMED, INC.	Nihon Kohden MSK3314P	2022-10-19
GUDID 10843685100057 NIHON KOHDEN ORANGEMED, INC.	Nihon Kohden MSK3313P	2022-10-19
GUDID 00843685100135 NIHON KOHDEN ORANGEMED, INC.	Nihon Kohden EXH3301P	2022-10-19
GUDID 00843685100043 NIHON KOHDEN ORANGEMED, INC.	Nihon Kohden NKV-330	2022-07-26
PMN K213521 Nihon Kohden OrangeMed, Inc.	Nihon Kohden NKV-330 Ventilator System	2022-07-01
GUDID 00843685100036 NIHON KOHDEN ORANGEMED, INC.	Nihon Kohden DSP5500A	2020-04-06
GUDID 00843685100029 NIHON KOHDEN ORANGEMED, INC.	Nihon Kohden NKV-550-N	2020-03-30
GUDID 00843685100012 NIHON KOHDEN ORANGEMED, INC.	Nihon Kohden NKV-550-U	2020-03-30
GUDID 00843685100005 NIHON KOHDEN ORANGEMED, INC.	Nihon Kohden NKV-550-S	2020-03-30
PMN K192307 Nihon Kohden OrangeMed, Inc.	Nihon Kohden NKV-550 Series Ventilator System	2020-01-10
PMN K181695 | CBK NIHON KOHDEN ORANGEMED, INC.	Nihon Kohden NKV-550 Series Ventilator System	2018-12-12
PMN K181695 Nihon Kohden OrangeMed, Inc.	Nihon Kohden NKV-550 Series Ventilator System	2018-12-07

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202009258743	Stadersand,Federal Republic of Germany -> Houston, Texas	AIR COMPRESSOR	176 BOX
2020091233991	Stadersand,Federal Republic of Germany -> Houston, Texas	AIR COMPRESSOR	176 BOX
2020082237928	Kaohsiung,China (Taiwan) -> Long Beach, California	MACHINED PARTS SUPPORT BLOCK (634CTNS=13PALLE .	634 CTN
2020082137460	Kaohsiung,China (Taiwan) -> Long Beach, California	MACHINED PARTS SUPPORT BLOCK (634CTNS=13PALLE .	634 CTN
2020081569790	Kaohsiung,China (Taiwan) -> Long Beach, California	MACHINED PARTS SUPPORT BLOCK (635CTNS=13PALLE .	635 CTN
2020080710277	Kaohsiung,China (Taiwan) -> Los Angeles, California	MACHINED PARTS MANIFOLD, CROSSOVER MODULE FLA Y (108CTNS=4PALLETS)	108 CTN
2020073144683	Shanghai ,China (Mainland) -> Los Angeles, California	OUTER HOUSING	24 CTN
2020072821146	Kaohsiung,China (Taiwan) -> Los Angeles, California	MACHINED PARTS MANIFOLD, CROSSOVER MODULE FLA Y (108CTNS=4PALLETS)	108 CTN