22 results · 23ms · Sources: EU EUDAMED, US FDA

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INFORMER PLUS

FDA 510(k)
FDA Class 1 ·General Hospital

MODIFICATION TO: ZILVER 635 BILIARY STENT

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

IntellaMap Orion High Resolution Mapping Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 15, 2025

GYNECARE MESH UNKNOWN

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·July 27, 2015

ARTICULEZE M HEAD 36MM -2

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·February 5, 2013

PK DISSECTING FORCEPS INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 18, 2014

ZILVER 635 BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·May 25, 2011

INTELLAMAP ORION?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·January 30, 2026

ZILVER 635 BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD.·Product code FGE·April 11, 2011

ZILVER 635 BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·September 5, 2012

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·November 21, 2024

INTELLAMAP ORION?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·February 26, 2026

ZILVER 635 SELF EXPANDING BILIARY STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·June 13, 2014

ZILVER 635 BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·May 30, 2014

ZILVER 635 BILIARY SELF EXPANDING STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·February 13, 2012

ZILVER 635 SELF-EXPANDING BILIARY STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·July 2, 2014

ZILVER 635 SELF-EXPANDING BILIARY STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·July 16, 2014

ZILVER 635 BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD.·Product code FGE·April 14, 2011

INTELLAMAP ORION

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·December 12, 2024