4 results
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51ms
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Sources: EU EUDAMED, US FDA
UNK_TECNIS SYMFONY
FDA Adverse Event
Injury
·AMO MANUFACTURING NETHERLANDS·Product code POE·March 23, 2021
Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.
FDA Recall
Terminated
·Bioseal Corporation·Product code BZA·August 15, 2019
Obelis s.a.
Authorized representative
🇧🇪 Belgium·546 Manufacturers·18515 Devices
Emergo Europe B.V.
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🇳🇱 Netherlands·900 Manufacturers·22100 Devices