729 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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High-speed Turbine Handpieces for Single Use
FDA UDI
Beijing Dongbo Dental Handpiece Co.,Ltd.·06970278690019·
High-speed Turbine Handpieces for Single Use
FDA UDI
Beijing Dongbo Dental Handpiece Co.,Ltd.·06970278690040·
VITROS SALI SLIDES
FDA Adverse Event
Malfunction
·JOHNSON &JOHNSON CLINICAL DIAGNOSTICS·Product code DKJ·August 30, 1996
VITROS CHEMISTRY PRODUCTS SALICYLATE SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code DKJ·October 8, 2008
VITROS CHEMISTRY PRODUCTS SALICYLATE SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code DKJ·October 8, 2008
VITROS CHEMISTRY PRODUCTS SALICYLATE SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code DKJ·October 8, 2008
VITROS CHEMISTRY PRODUCTS SALICYLATE SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code DKJ·October 8, 2008
VITROS CHEMISTRY PRODUCTS SALICYLATE SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code DKJ·October 8, 2008
UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER
FDA Adverse Event
Injury
·BECKMAN COULTER INC.·Product code DKJ·March 4, 2011
DIMENSION VISTA
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code DKJ·June 29, 2020
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code DKJ·March 16, 2011
ANALYTICAL P MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code DKJ·July 22, 2009
DIMENSION® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DKJ·November 30, 2011
DIMENSION® CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DKJ·August 1, 2012
VITROS SALI CHEMISTRY SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DKJ·May 31, 2007
UNICEL® DXC 800 SYNCHRON® SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code DKJ·September 11, 2013
ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code DKJ·June 29, 2017
Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human serum or plasma.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code DKJ·April 3, 2017
TDx/TDxFLx Salicylate, list 9533-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code DKJ--·December 5, 2003
VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog number 1314343 VITROS SALI Slides quantitatively measure salicylate (SALI) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code DKJ·June 12, 2013