15 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Discovery MI
FDA 510(k)
FDA Class 2
·Radiology
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
FDA 510(k)
FDA Class 2
·Hematology
ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0
FDA 510(k)
FDA Class 2
·Clinical Toxicology
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·March 31, 2016
COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code MPB·December 19, 2016
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·HOLOGIC·Product code MNB·May 6, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 14, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·October 10, 2014
COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code MPB·August 1, 2018
COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET
FDA Adverse Event
Injury
·COOK INC·Product code MPB·June 13, 2017
COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code MPB·January 14, 2020
COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code MPB·January 14, 2020
COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET
FDA Adverse Event
Injury
·COOK INC·Product code MPB·March 19, 2018
COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code MPB·June 7, 2018
COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code MPB·July 11, 2019