BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    AQUA IONOFIL

    FDA 510(k)
    FDA Class 2 ·Dental

    NOVEL FIT AND FILL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENDOTACK

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCESS® TOXO IGG

    FDA Adverse Event
    BECKMAN COULTER, INC.·Product code LGD·February 17, 2012

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 18, 2013

    CAPSURE Z NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·July 9, 2014

    ACCESS SARS-COV-2 ANTIGEN

    FDA Adverse Event
    Malfunction ·CLARE DISCRETE MFG IO·Product code QKP·May 21, 2021

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020