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

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    BIO-CAL 370 HEATER/COOLER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRISMA DISPOSABLE LEWICKY CHAMBER MAINTAINER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    3MHZ ANNULAR ARRAY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    M2A-MAGNUM MOD HD SZ 52MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·November 8, 2017

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·June 25, 2014

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·January 3, 2013

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·November 5, 2010

    PAEDIATRIC CANNULA, VENOUS

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DWF·June 7, 2023

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014