496 results
·
73ms
·
Sources: EU EUDAMED, US FDA
0.8% SELECTOGEN
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code MWN·June 22, 2009
ANTI-BIOCLONE
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code KSZ·July 2, 2009
ANTI-A BIOCLONE
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code KSZ·July 2, 2009
ADVIA AUTOSLIDE SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code KPA·July 25, 2016
ADVIA AUTOSLIDE SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code KPA·July 11, 2016
ADVIA AUTOSLIDE SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code KPA·July 25, 2016
EQUINOX
FDA Adverse Event
Malfunction
·CAIRE INC.·Product code CAW·April 24, 2020
OCULUS PENTACAM
FDA Adverse Event
Malfunction
·OCULUS OPTIKGERATE GMBH·Product code MXK·November 7, 2025
ADVIA AUTOSLIDE SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code KPA·July 11, 2016
ADVIA AUTOSLIDE SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code KPA·July 11, 2016
ADVIA 1800
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·September 20, 2011
0.8% SELECTOGEN
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code KSZ·July 21, 2009
*
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code KSZ·August 11, 2006
0.8% RESOLVE PANEL C FOR GEL
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code MWN·July 2, 2009
CT INJECTOR CEILING SUPPORT
FDA Adverse Event
Malfunction
·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·December 13, 2019
HEMATEK 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code KPA·February 3, 2015
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
BECKMAN COULTER INC.·Product code JJE·August 13, 2010
Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·September 20, 2017
ADVIA AUTOSLIDE SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INCL·Product code KPA·August 19, 2016
ADVIA 1800
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·August 4, 2017