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

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    NeutrArt

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CODMAN

    FDA UDI
    Cerenovus, Inc.·10886704002574·CODMAN Slimline Temporary Aneurysm Clip No 6 Bl...

    Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Widex

    FDA UDI
    Widex A/S·05706069728385·Widex EVOKE E-FS (Deep Blue S-330 ) Telecoil, R...

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·June 15, 2023

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code IKX·October 27, 2014

    COMP FX HUM POS SLEEVE 10MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·July 2, 2013

    TRIFECTA¿ GT VALVE

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code LWR·September 5, 2023

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LWS·October 24, 2018

    LOTUS VALVE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NPT·May 13, 2021

    LOTUS VALVE SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code NPT·May 13, 2021

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·June 1, 2022

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·June 1, 2022

    COREVALVE TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 4, 2020

    UNK - CONSTRUCTS: PLATE/SCREWS

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·November 2, 2020

    UNK - SCREWS: TRAUMA

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·November 2, 2020

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·October 28, 2021

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021