141 results · 35ms · Sources: EU EUDAMED, US FDA

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ARTHROCARE ARTHROWANDS

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ZILVER 635 SELF-EXPANDING BILIARY STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·September 1, 2022

ZILVER 635 SELF-EXPANDING BILIARY STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·August 29, 2022

ZILVER 635 SELF-EXPANDING BILIARY STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·August 26, 2022

ZILVER 635 SELF-EXPANDING BILIARY STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·August 9, 2022

ZILVER 635 SELF-EXPANDING BILIARY STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·June 18, 2024

ZILVER 635 SELF-EXPANDING BILIARY STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·August 26, 2022

ZILVER BILIARY SELF-EXPANDING METAL STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·April 6, 2020

ZILVER BILIARY SELF-EXPANDING METAL STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·April 6, 2020

ZILVER BILIARY SELF-EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·April 7, 2020

ZILVER BILIARY SELF-EXPANDING METAL STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·April 7, 2020

ZILVER BILIARY SELF-EXPANDING METAL STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·April 6, 2020

ZILVER 635 SELF-EXPANDING BILIARY STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·December 4, 2024

ZILVER 635 SELF-EXPANDING BILIARY STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·December 4, 2024

ZILVER 635 SELF-EXPANDING BILIARY STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·December 11, 2024

ZILVER 635 SELF-EXPANDING BILIARY STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·December 4, 2024

ZILVER 635 SELF-EXPANDING BILIARY STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·January 3, 2020

ZILVER 635 SELF-EXPANDING BILIARY STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code NIU·January 3, 2020