12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Confirm Rx Insertable Cardiac Monitor (ICM) System
FDA 510(k)
FDA Class 2
·Cardiovascular
COTRONIC DIGITAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
BC-3200 AUTO HEMATOLOGY ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
CONTOUR PLUS ELITE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 22, 2024
CONTOUR PLUS ELITE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 1, 2023
ELECSYS FT4 III ASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEC·January 15, 2021
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·June 11, 2013
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·July 8, 2011
HEARTSTREAM XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 10, 2008
ELECSYS FT3 III
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CDP·November 14, 2018
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 10, 2023
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·October 23, 2023