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

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    ABL330 ACID BASE LABORATORY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PREMIER® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490482141·BONE SCREW 6860057 SELF TAPPING 4.5X17MM

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AND MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code DYE·October 4, 2013

    ArcCHECK-MR

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM

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

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·June 16, 2017

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC INC.·Product code KRG·June 10, 2014

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 31, 2012

    FMP HIP

    FDA Adverse Event
    Malfunction ·ENCORE MEDICAL, L.P.·Product code HTW·September 17, 2010

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES

    SEE H10

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DYE·August 29, 2014

    SEE H10

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·April 15, 2014

    SEE H11

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·July 23, 2024

    CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·May 14, 2019

    SEE H10

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·September 1, 2017

    SEE H10

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·February 18, 2015

    SEE H10.

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·September 15, 2023

    IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 14, 2018

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDFIAL AORTIC BIOPROSTHESIS

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS