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

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    Filters Regulation: Us FDA ×

    Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TACTIPEN

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HYDROCOIL EMBOLIC SYSTEM (HES)

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDFUSION

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FRN·February 10, 2023

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 18, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·July 28, 2011

    OT PING ENHANCED METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 26, 2024

    ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·November 23, 2021

    ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE

    FDA Adverse Event
    Injury ·COOK INC·Product code DQX·January 30, 2023

    NELLCOR

    FDA Adverse Event
    Malfunction ·NELLCOR PURITAN BENNETT IRELAND·Product code DQA·February 5, 2024

    Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

    FDA Enforcement
    Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023