12 results
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36ms
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Sources: EU EUDAMED, US FDA
Vado
FDA UDI
KALILA MEDICAL, INC.·00810591020222·Steerable Sheath, Bidirectional
Vado
FDA UDI
KALILA MEDICAL, INC.·00810591020239·Steerable Sheath, Unidirectional (200 degrees)
CrossWise
FDA UDI
KALILA MEDICAL, INC.·00850021246082·Steerable Transseptal Sheath
Vado
FDA UDI
KALILA MEDICAL, INC.·00810591020215·Steerable Sheath, Unidirectional (140 degrees)
Nagare
FDA UDI
KALILA MEDICAL, INC.·00861705000425·Steerable Sheath, Bi-Directional
TRANSSEPTAL SHEATH
FDA Adverse Event
Injury
·ABBOTT; KALILA MEDICAL·Product code DYB·August 12, 2023
NAGARE
FDA Adverse Event
Malfunction
·KALILA MEDICAL, INC.·Product code DYB·November 17, 2020
Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.
FDA Enforcement
Class II
·Terminated·Kalila Medical·February 21, 2018
Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.
FDA Enforcement
Class II
·Terminated·Kalila Medical·February 21, 2018
Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.
FDA Recall
Terminated
·Kalila Medical·Product code DYB·December 14, 2017
Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.
FDA Recall
Terminated
·Kalila Medical·Product code DYB·December 14, 2017
EDWARDS PASCAL PRECISION
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NKM·November 26, 2025