BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    SpectraShield 9500 Surgical N95 Respirator

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ALCON MULTI-PURPOSE DISINFECTING SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CHLORAPREP ONE-STEP

    FDA Adverse Event
    Injury ·CAREFUSION, INC·Product code KXG·December 30, 2020

    CHLORAPREP ONE-STEP

    FDA Adverse Event
    Injury ·CAREFUSION, INC·Product code KXG·January 4, 2021

    VERSACROSS CONNECT LAAC ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - THETFORD·Product code LHI·June 6, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 6, 2011

    LEAD MODEL UNK

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·September 3, 2008

    ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·January 15, 2016

    VERSACROSS ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 19, 2023

    Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.

    FDA Enforcement
    Class II ·Terminated·Advanced Bionics, LLC·April 10, 2019

    VERSACROSS ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DYB·April 20, 2023

    VERSACROSS CONNECT LAAC ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023

    O-ARM 1000 IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OXO·March 9, 2020