Coeur Inc

FDA Filings

This page includes the latest FDA filings for Coeur 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: 1038185
• FEI Number: 1038185
• Name: COEUR, INC.
• Owner & Operator: COEUR, INC. ( a subsidiary of ITW Medical)
• Contact Address: 209 Creekside Drive ; Washington NC 27889 US
• Official Correspondent:
  • DEBRA F MANNING
  • x-615-5844193-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 209 Creekside Dr ; WASHINGTON, NC 27889 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K170431 | DXT COEUR, INC. [COEUR, INC. ( a subsidiary of ITW Medical)]	Coeur Syringes for Stellant Injectors	2018-08-28
PMN K161471 | DXT COEUR, INC. [COEUR, INC. ( a subsidiary of ITW Medical)]	Coeur Syringes for Solaris Injectors	2018-08-28
PMN K170431 Coeur, Inc.	CT Syringe For Stellant Injectors (with & Without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack For Stellant Injectors (with & Without Spikes, Prime Tubes, & Fill Tubes), Single Fascia And Ram Tip, Dual Fascia And Ram Tip	2017-08-18
PMN K161471 Coeur, Inc.	MR Syringe Dual Pack For Solaris Injectors	2016-10-06
PMN K150902 COEUR, INC.	330psi Extension Y-Line With Dual Check Valve	2015-10-22
PMN K142745 | DXT COEUR, INC. [COEUR, INC. ( a subsidiary of ITW Medical)]	125mL CT Syringe	2015-05-04
PMN K142745 COEUR, INC.	125mL CT Syringe	2015-04-01
PMN K140469 | DXT COEUR, INC. [COEUR, INC. ( a subsidiary of ITW Medical)]	MR Syringe Dual Pack	2014-09-24
PMN K133600 | DXT COEUR, INC. [COEUR, INC. ( a subsidiary of ITW Medical)]	Front Load Adapter	2014-09-24
PMN K140469 COEUR, INC.	MR SYRINGE DUAL PACK	2014-07-28
PMN K133600 COEUR, INC.	COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR	2014-04-30
PMN K120892 COEUR, INC.	DISPOSABLE 330PSI EXTENSION LINES	2013-06-10
PMN K113498 COEUR, INC.	DISPOSABLE TORQUE DEVICE	2012-07-20
PMN K113132 COEUR, INC.	DISPOSABLE HEMOSTATIC Y-CONNECTORS	2012-01-20
PMN K090487 | DXT COEUR, INC. [COEUR, INC. ( a subsidiary of ITW Medical)]	Disp Angio Syr for Nemoto Injectors	2010-02-04
PMN K090487 COEUR, INC.	DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150	2009-10-19
PMN K071196 | DQO COEUR, INC. [COEUR, INC. ( a subsidiary of ITW Medical)]	High Pressure Injection Lines	2008-03-25
PMN K960965 | DXT COEUR, INC. [COEUR, INC. ( a subsidiary of ITW Medical)]	Coeur 200mL FrontLoad Syringe	2008-01-11
PMN K942381 | DXT COEUR, INC. [COEUR, INC. ( a subsidiary of ITW Medical)]	Low Pressure Injection Extension Tu	2008-01-11
PMN K873597 | DXT COEUR, INC. [COEUR, INC. ( a subsidiary of ITW Medical)]	Fill Tube	2008-01-11
PMN K823920 | DXT COEUR, INC. [COEUR, INC. ( a subsidiary of ITW Medical)]	Coeur Sterile Syringe	2008-01-11
PMN K070798 | DXT COEUR, INC. [COEUR, INC. ( a subsidiary of ITW Medical)]	Adp/Pres Jkt for CT&Angio Pwr Inj	2008-01-11
PMN K051799 | DXT COEUR, INC. [COEUR, INC. ( a subsidiary of ITW Medical)]	CT-MR Syringes	2008-01-11
PMN K032920 | DXT COEUR, INC. [COEUR, INC. ( a subsidiary of ITW Medical)]	Injector Adapter/Pressure Jacket	2008-01-11
PMN K971712 | DXT COEUR, INC. [COEUR, INC. ( a subsidiary of ITW Medical)]	Coeur, Inc. Angiographic Syringes	2008-01-04
PMN K070798 COEUR, INC.	ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS	2007-10-04
PMN K071196 COEUR, INC.	DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS	2007-09-06
PMN K063114 | FPK COEUR, INC. [COEUR, INC. ( a subsidiary of ITW Medical)]	DISP. TRANSFER SETS W-WO SWAB	2007-06-27
PMN K063114 | FPA COEUR, INC. [COEUR, INC. ( a subsidiary of ITW Medical)]	DISP. TRANSFER SETS W-WO SWAB	2007-06-27
PMN K063114 COEUR, INC.	DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES	2007-02-09
PMN K051799 COEUR, INC.	DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS	2005-11-02

Similar & Related FDA Registered Companies

• COEUR LABORATORIES, INC.

Related Finance Registrations

NCAGE Code	82XD8	COEUR INC
NCAGE Code	4PN54	COEUR INC.!DBA COEUR MEDICAL
CAGE Code	4PN54	COEUR INC. COEUR MEDICAL
CAGE Code	82XD8	COEUR INC
SEC	0001233651	COEUR INC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091966125	Puerto Limon,Costa Rica -> Wilmington, North Carolina	PLASTIC TUBES FOR MEDICAL DEVICE	10 PKG
2020091858305	Puerto Limon,Costa Rica -> Wilmington, North Carolina	PLASTIC TUBES FOR MEDICAL DEVICE	10 PKG
2020082151962	Puerto Manzanillo,Panama -> Wilmington, North Carolina	PLASTIC TUBES FOR MEDICAL DEVICE	10 PKG
2020081922350	Tokyo ,Japan -> Los Angeles, California	BULK PARTS FOR DISPOSABLE SYRINGE	35 CTN
2020081138958	Tokyo ,Japan -> Los Angeles, California	BULK PARTS FOR DISPOSABLE SYRINGE	35 CTN
2020080751573	Tokyo ,Japan -> Los Angeles, California	BULK PARTS FOR DISPOSABLE SYRINGE	35 CTN
2020073166970	Tokyo ,Japan -> Los Angeles, California	BULK PARTS FOR DISPOSABLE SYRINGE	35 CTN
2020070328234	Puerto Manzanillo,Panama -> Wilmington, North Carolina	PLASTIC TUBES FOR MEDICAL DEVICE	20 PKG