7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DART UREA NITROGEN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER
FDA 510(k)
FDA Class 2
·Microbiology
L.A.P. SPIROMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 25, 2014
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·December 20, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·November 5, 2010
Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 14, 2013