18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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