18 results · 22ms · Sources: EU EUDAMED, US FDA

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BLOOD ADMINISTRATION SET

FDA 510(k)
FDA Class 2 ·General Hospital

WILSON-COOK ZILVER BILIARY STENT

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

CLIRANS PRIMING SET

FDA 510(k)
FDA Class 2 ·General Hospital

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·December 17, 2018

ZILVER BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·March 5, 2020

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·September 26, 2018

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·August 24, 2018

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·August 24, 2018

MINICAP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·January 17, 2013

SIGMA 100 VVI

FDA Adverse Event
Injury ·MEDTRONIC OF CANADA LTD.·Product code DXY·December 13, 2010

ACCENT DR RF

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·August 2, 2018

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·March 5, 2020

FGE CATHETER, BILIARY, DIAGNOSTIC

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·March 13, 2019

ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026