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

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    ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Oticon

    FDA UDI
    Oticon A/S·05707131256409·NERA, BTE 13 WL 85 CNB

    SCOUTPRO ACS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MC2X MULTI-STAGE VENOUS CANNULA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CANTATA 2.9 SUPERSELECTIVE MICROCATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·September 14, 2017

    OT VERIO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    ATTAIN OTW

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 1, 2014

    FUSION 8MM-40CM UNSUPP PERIPHERAL GRAFT

    FDA Adverse Event
    Malfunction ·MAQUET CV·Product code DSY·February 8, 2017

    Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

    FDA Enforcement
    Class I ·Ongoing·Edwards Lifesciences, LLC·July 16, 2025