2,514 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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I-STAT CG4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·October 1, 2024
COBAS B 221 <6> SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CHL·March 30, 2026
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015
VITROS CHEMISTRY PRODUCTS LAC SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code KHP·November 17, 2016
VITROS CHEMISTRY PRODUCTS LAC SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code KHP·November 17, 2016
VITROS CHEMISTRY PRODUCTS LAC SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code KHP·November 17, 2016
ARCHITECT LACTIC ACID
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code KHP·November 29, 2016
ARCHITECT LACTIC ACID
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code KHP·October 24, 2016
VITROS CHEMISTRY PRODUCTS LAC SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code KHP·November 3, 2016
RAPIDPOINT 500
FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS·Product code KHP·September 2, 2015
DIMENSION VISTA (R) CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code KHP·January 4, 2012
RAPIDPOINT 500
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code KHP·April 2, 2014
RAPIDPOINT 500
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code KHP·April 22, 2014
RAPIDLAB 1265
FDA Adverse Event
Other
·SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD.·Product code KHP·March 1, 2010
VITROS CHEMISTRY PRODUCTS LAC SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code KHP·November 17, 2016
RAPIDPOINT 500
FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS·Product code KHP·September 10, 2015
RAPIDPOINT 500
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code KHP·July 10, 2015
RAPIDPOINT 500
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code KHP·July 27, 2015
RAPIDPOINT 500
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code KHP·August 28, 2015
RAPIDPOINT 500
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code KHP·July 10, 2015