Atlas FDA

Coeur, Inc.

14 FDA 510(k) clearances · Manufacturer

Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
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 (K170431)Coeur, Inc.2017-08-18
MR Syringe Dual Pack for Solaris Injectors (K161471)Coeur, Inc.2016-10-06
330psi Extension Y-Line with Dual Check Valve (K150902)Coeur, Inc.2015-10-22
125mL CT Syringe (K142745)Coeur, Inc.2015-04-01
MR SYRINGE DUAL PACK (K140469)Coeur, Inc.2014-07-28
COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR (K133600)Coeur, Inc.2014-04-30
DISPOSABLE 330PSI EXTENSION LINES (K120892)Coeur, Inc.2013-06-10
DISPOSABLE TORQUE DEVICE (K113498)Coeur, Inc.2012-07-20
DISPOSABLE HEMOSTATIC Y-CONNECTORS (K113132)Coeur, Inc.2012-01-20
DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150 (K090487)Coeur, Inc.2009-10-19
ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS (K070798)Coeur, Inc.2007-10-04
DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS (K071196)Coeur, Inc.2007-09-06
DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES (K063114)Coeur, Inc.2007-02-09
DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS (K051799)Coeur, Inc.2005-11-02

Track Coeur, Inc. automatically

Every clearance here is in the API, with alerts when new ones post.