9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
IRON(IRN) TESTPACK, ITEM NO. 67659/95
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GC Initial™
FDA UDI
Gc America Inc.·15400556701796·GC Initial™ MC Inside IN-44 Sand, 20g
GC Initial™
FDA UDI
Gc America Inc.·J0228701441·GC Initial™ MC Inside IN-44 Sand, 20g
StentBoost Live
FDA 510(k)
FDA Class 2
·Radiology
INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CELSIUS THERMO-COOL ELECTROPHYSIOLOGY CATHETER
FDA Adverse Event
Death
·BIOSENSE WEBSTER·Product code DRF·June 6, 2014
PORTEX PENCIL POINT SPINAL ANESTHESIA TRAYS
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC·Product code CAZ·December 3, 2012
PUMP MMT-712RNAB PRDGM INS BL EN US RC
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LGZ·October 11, 2010
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015