BEUDAMED
    22 results · 27ms · Sources: EU EUDAMED, US FDA

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    MIRAGE, RELEASE 5.5

    FDA 510(k)
    FDA Class 2 ·Radiology

    Denzel Medical GmbH & Co. KG

    FDA registration
    Denzel Medical GmbH & Co. KG·33 products·🇩🇪 Germany

    CASTLE MODEL 233HC STEAM STERILIZER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ISOLA POLYAXIAL WASHER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 12, 2013

    FUSION OMNI-TOME SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·February 25, 2011

    SELUTE PICOTIP

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

    ZILVER 635 BILIARY SELF-EXPANDING STENT

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

    RUNWAY GUIDE CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 8, 2013

    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

    ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 06597065, 2) 4 F Stiffened Micro-Introducer Kit, STF 4F M.I. KIT 45CM NT/T NON-ECHO S PG, Item Number H787065970695, Catalog No.REF 06597069 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick

    FDA Enforcement
    Class III ·Terminated·Angiodynamics, Inc.·December 28, 2016

    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

    LGN PRSFT STEM 10MMX220MM STRT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·October 19, 2017

    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

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·February 1, 2012