298 results
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Sources: EU EUDAMED, US FDA
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Country: France
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Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in preparation for transportation and eventual transplantation of the heart into the recipient. Celsior is packaged in one liter bag with 4 units per carton box. Celsior shall be stored between 36¿ to 46¿F. In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas).
FDA Enforcement
Class II
·Ongoing·INSTITUT GEORGES LOPEZ·August 6, 2025
FRANCO&FILS
Device
EU MDD
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Eu Md Class 1
·ETABLISSEMENTS FRANCO ET FILS·On the market
FRANCO&FILS
Device
EU MDD
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Eu Md Class 1
·ETABLISSEMENTS FRANCO ET FILS·On the market
FRANCO&FILS
Device
EU MDD
·
Eu Md Class 1
·ETABLISSEMENTS FRANCO ET FILS·On the market
FRANCO&FILS
Device
EU MDD
·
Eu Md Class 1
·ETABLISSEMENTS FRANCO ET FILS·On the market
FRANCO&FILS
Device
EU MDD
·
Eu Md Class 1
·ETABLISSEMENTS FRANCO ET FILS·On the market
FRANCO&FILS
Device
EU MDD
·
Eu Md Class 1
·ETABLISSEMENTS FRANCO ET FILS·On the market
FRANCO&FILS
Device
EU MDD
·
Eu Md Class 1
·ETABLISSEMENTS FRANCO ET FILS·On the market
FRANCO&FILS
Device
EU MDD
·
Eu Md Class 1
·ETABLISSEMENTS FRANCO ET FILS·On the market
FRANCO&FILS
Device
EU MDD
·
Eu Md Class 1
·ETABLISSEMENTS FRANCO ET FILS·On the market
FRANCO&FILS
Device
EU MDD
·
Eu Md Class 1
·ETABLISSEMENTS FRANCO ET FILS·On the market
FRANCO&FILS
Device
EU MDD
·
Eu Md Class 1
·ETABLISSEMENTS FRANCO ET FILS·On the market
FRANCO&FILS
Device
EU MDD
·
Eu Md Class 1
·ETABLISSEMENTS FRANCO ET FILS·On the market
FRANCO&FILS
Device
EU MDD
·
Eu Md Class 1
·ETABLISSEMENTS FRANCO ET FILS·On the market
FRANCO&FILS
Device
EU MDD
·
Eu Md Class 1
·ETABLISSEMENTS FRANCO ET FILS·On the market
FRANCO&FILS
Device
EU MDD
·
Eu Md Class 1
·ETABLISSEMENTS FRANCO ET FILS·On the market
FRANCO&FILS
Device
EU MDD
·
Eu Md Class 1
·ETABLISSEMENTS FRANCO ET FILS·On the market
FRANCO&FILS
Device
EU MDD
·
Eu Md Class 1
·ETABLISSEMENTS FRANCO ET FILS·On the market
FRANCO&FILS
Device
EU MDD
·
Eu Md Class 1
·ETABLISSEMENTS FRANCO ET FILS·On the market
FRANCO&FILS
Device
EU MDD
·
Eu Md Class 1
·ETABLISSEMENTS FRANCO ET FILS·On the market