42 results
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54ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Digital Diagnostics Inc.
FDA registration
Digital Diagnostics Inc.·1 product·🇺🇸 United States
IDx-DR
FDA UDI
Digital Diagnostics Inc.·00860005195626·
IDx-DR
FDA UDI
Digital Diagnostics Inc.·00860005195619·
DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code JFY·September 17, 2012
DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code JFY·September 17, 2012
DIMENSION VISTA(R) CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code JFY·November 25, 2013
DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code JFY·June 14, 2012
ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code GKZ·December 23, 2015
VITROS CHEMISTRY PRODUCTS PHYT SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DIP·September 1, 2022
ID NOW COVID-19 2.0 TEST KIT 24T JAPAN
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·August 4, 2025
ADVIA 2120I WTH DUAL ASPIRATE AUTOSAMPLER
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code GKZ·July 18, 2014
NAVISTAR® THERMOCOOL®
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code OAD·August 26, 2014
NAVISTAR® THERMOCOOL®
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code OAD·August 26, 2014
VITROS 5600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·April 13, 2010
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·December 12, 2024
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code MIH·July 16, 2018
GORE® EXCLUDER® AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·May 22, 2025
DAVINCI 5
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·March 25, 2026
BINAXNOW STREP PNEUMONIAE 12T
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code GTZ·March 27, 2025
Immulite 2000 and Immulite 2500 digital Fluidics PC Board, Part Number 450116-0002. Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnostic testing.
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code DGC·January 5, 2009