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 Number1039215
FEI Number1039215
NameNIDEK MEDICAL PRODUCTS, INC.
Owner & OperatorNIDEK MEDICAL PRODUCTS, INC.
Contact Address3949 VALLEY EAST INDUSTRIAL DR --
Birmingham AL 35217 US
Official Correspondent
  • Olivia H Mullen
  • x-205-8567200-220
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3949 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
DeviceDate
Nidek Medical Products, Inc.
Nuvo Nano Portable Oxygen Concentrator2020-05-07
NIDEK MEDICAL PRODUCTS, INC.
Max 30 (3005, 3010)2018-05-18
NIDEK MEDICAL PRODUCTS, INC.
Multi Flow (Freestanding)2018-05-17
NIDEK MEDICAL PRODUCTS, INC.
Dual Flow (Remote Mounting)2018-05-17
NIDEK MEDICAL PRODUCTS, INC.
Mark 5 Nuvo Lite STD (520, 920)2015-10-27
NIDEK MEDICAL PRODUCTS, INC.
Mark 5 Nuvo Lite OCSI (525, 925)2015-10-27
NIDEK MEDICAL PRODUCTS, INC.
Mark 5 Nuvo Lite 3 (935)2015-10-27
NIDEK MEDICAL PRODUCTS, INC.
GCE Mediline Nuvo Lite (925GC)2015-10-27
NIDEK MEDICAL PRODUCTS, INC.
MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD2013-02-28
NIDEK MEDICAL PRODUCTS, INC.
New Aera Source 5 (565NA)2010-03-08
NIDEK MEDICAL PRODUCTS, INC.
Mark 5 Nuvo 8 STD (580, 980)2010-03-08
NIDEK MEDICAL PRODUCTS, INC.
Mark 5 Nuvo 8 OCSI (585, 985)2010-03-08
NIDEK MEDICAL PRODUCTS, INC.
Mark 5 Nuvo 10 OCSI (595, 1005)2010-03-08
NIDEK MEDICAL PRODUCTS, INC.
Mark 5 Nuvo (505, 565, 905, 965)2010-03-08
NIDEK MEDICAL PRODUCTS, INC.
GCE Mediline Nuvo 8 (985GC, 985GCUK)2010-03-08
NIDEK MEDICAL PRODUCTS, INC.
MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD2010-01-14
NIDEK MEDICAL PRODUCTS, INC.
MARK 5 NUVO LITE OCSI AND STD2008-12-03
NIDEK MEDICAL PRODUCTS, INC.
Pulmo-Mist Compressor2007-11-12
NIDEK MEDICAL PRODUCTS, INC.
Pulmo-Mist Compressor2007-11-12
NIDEK MEDICAL PRODUCTS, INC.
MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 9052004-04-29
NIDEK MEDICAL PRODUCTS, INC.
SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM1998-11-17
NIDEK MEDICAL PRODUCTS, INC.
SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM1997-01-23
NIDEK MEDICAL PRODUCTS, INC.
CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM1996-05-07
NIDEK MEDICAL PRODUCTS, INC.
OXYCHEK OXYGEN ANALYZER1995-05-03
NIDEK MEDICAL PRODUCTS, INC.
MARK-5 CONCENTRATOR1988-11-02

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