34 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Contour® next GEN Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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
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
COTRONIC DIGITAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
ZQUIET MOUTHPIECE
FDA 510(k)
FDA Class 2
·Dental
BD INSYTE AUTOGUARD BC 20GA X1.16 IN
FDA Adverse Event
Injury
·BECTON DICKINSON·Product code FOZ·October 9, 2025
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·June 16, 2025
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·June 16, 2025
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·October 22, 2025
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·February 12, 2025
INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 24, 2025
AXIUM HELIX DETACHABLE COIL
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code HCG·October 7, 2008
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 27, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 5, 2011
INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 24, 2025
INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 24, 2025
CARDIOCHEK PLUS ANALYZERQ
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·August 18, 2022
BD INSYTE AUTOG BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 21, 2025