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

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    Cemented Round Patella with JRNY Pegs

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GAIA Lumbar Interbody Fusion Device (LIFD) Family

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VITALCARE FOLEY CATHETER

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

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·November 3, 2014

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·August 17, 2011

    REPLACEMENT HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·November 13, 2015

    8120 ALARIS PCA

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·September 24, 2020

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

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

    EDWARDS INSPIRIS RESILIA AORTIC VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·December 12, 2025

    EDWARDS INSPIRIS RESILIA AORTIC VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES LLC·Product code LWR·September 30, 2025

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES LLC·Product code DYE·November 25, 2025

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·December 26, 2024

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES LLC·Product code DYE·October 11, 2024

    EDWARDS INSPIRIS RESILIA AORTIC VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES LLC·Product code LWR·December 18, 2024

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·December 26, 2024

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES LLC·Product code DYE·May 6, 2025

    HERCULES 3 STAGE BALLOON ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNQ·September 16, 2019

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025