815 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AUTO-DISABLE SYRINGE, 0.5ML BD SOLOSHOT¿ IX
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 2, 2022
AUTO-DISABLE SYRINGE, 0.5ML BD SOLOSHOT¿ IX
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 2, 2022
PIIC IX HARDWARE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·January 12, 2018
INTELLIVUE INFORMATION CENTER
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·August 24, 2020
INTELLIVUE MX700 PATIENT MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 16, 2018
AUTO-DISABLE SYRINGE, 0.5ML BD SOLOSHOT¿ IX
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 2, 2022
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·July 1, 2009
PIC IX HARDWARE
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·February 7, 2023
Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info Center iX B.0 866025 IntelliVue Server IX A.0 866118 Database Server Upgrade A.0
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·March 7, 2018
INTELLIVUE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MSX·November 6, 2015
Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info Center iX B.0 866025 IntelliVue Server IX A.0 866118 Database Server Upgrade A.0
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code MHX·January 3, 2018
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 11, 2022
S-ICD SYSTEM
FDA Adverse Event
Malfunction
·CAMERON HEALTH INC.·Product code LWS·March 11, 2015
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·March 18, 2025
Philips Healthcare IntelliVue Info Center iX, A.0 866023
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code MHX·November 25, 2015
INTELLIVUE INFORMATION CENTER IX
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·September 24, 2018
INTELLIVUE INFORMATION CENTER IX
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·August 30, 2019
Philips Healthcare IntelliVue Info Center iX, A.0 866023
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·March 2, 2016
ADAPTOSIZE
FDA Adverse Event
TLK INDUSTRIES, INC.·Product code IXA·April 25, 1996
AUTOMATIC CASSETTE LOADER (ACL)
FDA Adverse Event
Injury
·LIEBEL-FLARSHEIM CO.·Product code IXA·July 24, 1998