Nidek Medical Products Inc

FDA Filings

This page includes the latest FDA filings for Nidek Medical Products 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: 1039215
• FEI Number: 1039215
• Name: NIDEK MEDICAL PRODUCTS, INC.
• Owner & Operator: NIDEK MEDICAL PRODUCTS, INC.
• Contact Address: 3949 VALLEY EAST INDUSTRIAL DR --; Birmingham AL 35217 US
• Official Correspondent:
  • Olivia H Mullen
  • x-205-8567200-220
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3949 VALLEY EAST INDUSTRIAL DR ; Birmingham, AL 35217 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
GUDID 00038214002732 NIDEK MEDICAL PRODUCTS, INC.	Penta Flow Oxygen Flow Splitter	2023-12-21
GUDID 00038214002466 NIDEK MEDICAL PRODUCTS, INC.	NUVO NANO 855	2023-06-15
PMN K192693 Nidek Medical Products, Inc.	Nuvo Nano Portable Oxygen Concentrator	2020-05-07
CAW NIDEK MEDICAL PRODUCTS, INC.	Max 30 (3005, 3010)	2018-05-18
CAX NIDEK MEDICAL PRODUCTS, INC.	Multi Flow (Freestanding)	2018-05-17
CAX NIDEK MEDICAL PRODUCTS, INC.	Dual Flow (Remote Mounting)	2018-05-17
PMN K123738 | CAW NIDEK MEDICAL PRODUCTS, INC.	Mark 5 Nuvo Lite STD (520, 920)	2015-10-27
PMN K123738 | CAW NIDEK MEDICAL PRODUCTS, INC.	Mark 5 Nuvo Lite OCSI (525, 925)	2015-10-27
PMN K123738 | CAW NIDEK MEDICAL PRODUCTS, INC.	Mark 5 Nuvo Lite 3 (935)	2015-10-27
PMN K123738 | CAW NIDEK MEDICAL PRODUCTS, INC.	GCE Mediline Nuvo Lite (925GC)	2015-10-27
PMN K123738 NIDEK MEDICAL PRODUCTS, INC.	MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD	2013-02-28
PMN K093308 | CAW NIDEK MEDICAL PRODUCTS, INC.	New Aera Source 5 (565NA)	2010-03-08
PMN K093308 | CAW NIDEK MEDICAL PRODUCTS, INC.	Mark 5 Nuvo 8 STD (580, 980)	2010-03-08
PMN K093308 | CAW NIDEK MEDICAL PRODUCTS, INC.	Mark 5 Nuvo 8 OCSI (585, 985)	2010-03-08
PMN K093308 | CAW NIDEK MEDICAL PRODUCTS, INC.	Mark 5 Nuvo 10 OCSI (595, 1005)	2010-03-08
PMN K093308 | CAW NIDEK MEDICAL PRODUCTS, INC.	Mark 5 Nuvo (505, 565, 905, 965)	2010-03-08
PMN K093308 | CAW NIDEK MEDICAL PRODUCTS, INC.	GCE Mediline Nuvo 8 (985GC, 985GCUK)	2010-03-08
PMN K093308 NIDEK MEDICAL PRODUCTS, INC.	MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD	2010-01-14
PMN K082566 NIDEK MEDICAL PRODUCTS, INC.	MARK 5 NUVO LITE OCSI AND STD	2008-12-03
PMN K020797 | CAF NIDEK MEDICAL PRODUCTS, INC.	Pulmo-Mist Compressor	2007-11-12
PMN K020797 | BTI NIDEK MEDICAL PRODUCTS, INC.	Pulmo-Mist Compressor	2007-11-12
PMN K040892 NIDEK MEDICAL PRODUCTS, INC.	MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905	2004-04-29
PMN K032509 NIDEK MEDICAL PRODUCTS, INC.	MARK 5 NUVO (M5C5)	2004-03-18
PMN K020797 NIDEK MEDICAL PRODUCTS, INC.	PULMO-MIST COMPRESSOR MODEL # 4323	2002-05-03
PMN K980551 NIDEK MEDICAL PRODUCTS, INC.	SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM	1998-11-17
PMN K962492 NIDEK MEDICAL PRODUCTS, INC.	SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM	1997-01-23
PMN K952966 NIDEK MEDICAL PRODUCTS, INC.	CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM	1996-05-07
PMN K942593 NIDEK MEDICAL PRODUCTS, INC.	OXYCHEK OXYGEN ANALYZER	1995-05-03
PMN K883591 NIDEK MEDICAL PRODUCTS, INC.	MARK-5 CONCENTRATOR	1988-11-02

Related Finance Registrations

NCAGE Code	0UJP1	NIDEK MEDICAL PRODUCTS, INC.
CAGE Code	0UJP1	NIDEK MEDICAL PRODUCTS, INC.
DUNS	161382940	Nidek Medical Products, Inc.
SEC	0000807499	NIDEK MEDICAL PRODUCTS INC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092140635	Shanghai ,China (Mainland) -> Los Angeles, California	OILLESS AIR PUMP COMPRESSOR	4 PKG
202008296108	Shanghai ,China (Mainland) -> Savannah, Georgia	COMPRESSOR	44 CTN
202008228762	Shanghai ,China (Mainland) -> Savannah, Georgia	COMPRESSOR	44 CTN
2020081815926	Shanghai ,China (Mainland) -> Savannah, Georgia	COMPRESSOR	44 CTN
20200805752	Ningpo ,China (Mainland) -> Savannah, Georgia	OILLESS AIR PUMP ZGK300P2-68(230V 50HZ) OILLESS AIR PUMP ZGK160P1-30(115V 60HZ) OILLESS AIR PUMP ZGK160P2-30(230V 50HZ) THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS	49 PKG
2020071816305	Shanghai ,China (Mainland) -> Savannah, Georgia	COMPRESSOR	44 CTN
2020062215198	Shanghai ,China (Mainland) -> Savannah, Georgia	COMPRESSOR	44 PKG
202006225010	Yantian,China (Mainland) -> Savannah, Georgia	ANION AIR REFRESHER PO#: 39192,39267 HS CODE:842199 THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS	814 CTN