59 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SBG Black Nitrile Powder Free Medical Examination Glove
FDA 510(k)
FDA Class 1
·General Hospital
LIASYS WITH MODELS LIASYS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ZEISS INFRARED 800 WITH FLOW 800 OPTION
FDA 510(k)
FDA Class 2
·Radiology
INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·May 5, 2020
INSPIRE 8F M
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·January 3, 2024
XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·June 20, 2013
MAINFRAME NIM RESPONSE 3.0
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code ETN·July 27, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·September 26, 2008
INSPIRE 8F M
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·January 4, 2024
INSPIRE OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·March 12, 2026
INSPIRE OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·March 12, 2026
INSPIRE 8F
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·November 5, 2025
INSPIRE 8F
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·November 5, 2025
INSPIRE OXYGENATOR
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·December 11, 2025
INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 20, 2021
INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·September 11, 2020
INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·December 23, 2020
INSPIRE 8F
FDA Adverse Event
Injury
·SORIN GROUP ITALIA SRL·Product code DTZ·July 24, 2025
BD PHOENIX PMIC110
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·October 19, 2021
BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·August 23, 2021