BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    CODERE-DURETTE ORBITAL FLOOR IMPLANT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DYONICS / BONECUTTER

    FDA UDI
    Smith & Nephew, Inc.·03596010510686·MTO BL BONECUTTER F/R

    ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4

    FDA 510(k)
    FDA Unclassified ·Unknown

    SURGIAID

    FDA 510(k)
    FDA Unclassified ·Unknown

    GEENEN PANCREATIC STENT SET

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·January 10, 2019

    INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·June 27, 2014

    L9000 LIGHTSOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·November 10, 2010

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 13, 2012

    GEENEN PANCREATIC STENT

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code FGE·September 14, 2018

    GEENEN PANCREATIC STENT

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code FGE·September 14, 2018

    GEENEN PANCREATIC STENT

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code FGE·September 14, 2018

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·June 9, 2021

    ZIMMON PANCREATIC STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·October 16, 2020

    UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·October 1, 2014