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Coeur, Inc.

FDA 510(k) & PMA Approved Devices — 2 products

Total Devices2
Categories1
Latest FDA decision2017-08-18
TypeNumberDevice NameCodeDateActions
510(k) K170431 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 TipDXT2017-08-18 View
510(k) K161471 MR Syringe Dual Pack for Solaris InjectorsDXT2016-10-06 View