BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    PELVX RING, PELVX RING WITH SUPPORT

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    n/a

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994309280·FORK 7974115 RELEASE 25MM

    NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)

    FDA 510(k)
    FDA Class 2 ·Immunology

    HYCOR ACCUPINCH METHAMPHETAMINE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIV.·Product code FNL·December 28, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·February 22, 2013

    SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·August 1, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021