Coeur Inc A Subsidiary Of Itw Medical

FDA Filings

This page includes the latest FDA filings for Coeur Inc A Subsidiary Of Itw Medical. 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 K142745 | DXT COEUR, INC. [COEUR, INC. ( a subsidiary of ITW Medical)]	125mL CT Syringe	2015-05-04
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 K090487 | DXT COEUR, INC. [COEUR, INC. ( a subsidiary of ITW Medical)]	Disp Angio Syr for Nemoto Injectors	2010-02-04
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 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