30 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED
FDA 510(k)
FDA Class 2
·Cardiovascular
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·December 29, 2025
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·February 19, 2026
HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·May 10, 2019
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code DTZ·March 10, 2017
INSPIRE 6F HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·August 3, 2022
INSPIRE 6 HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·February 25, 2022
INSPIRE 6
FDA Adverse Event
Death
·SORIN GROUP ITALIA SRL.·Product code DTZ·July 15, 2024
INSPIRE 6F M DUAL HOLLOW FIBER OXY W/ INTEGRATED HARDSHELL VENOUS CARDIOTOMY RES
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·October 17, 2018
INSPIRE 6F DUAL HOLLOW FIBER OXY W/ INTEGRATED HARDSHELL VEN/CARD RES
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·October 24, 2018
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·September 23, 2022
INSPIRE 6 STERILE
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL.·Product code DTZ·February 1, 2024
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·March 7, 2019
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·March 19, 2019
INSPIRE 6F
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·December 20, 2024
INSPIRE 6F
FDA Adverse Event
Malfunction
·SORIN GROUP ITALY·Product code DTZ·April 7, 2025
INSPIRE 6F HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER & HARDSHELL RES
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·June 29, 2018
HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·July 25, 2019
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·July 5, 2019
OsteoMed
FDA UDI
OSTEOMED LLC·00845694031493·1.6mm Modified LeFort Plate, Right, 6mm