BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    MODIFIED MODEL BIA-103 BODY COMPOSITION ANALYZER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNISYN HA PLASMA MODULAR HIP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Cadwell Sierra Summit, Cadwell Sierra Ascent

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 10, 2014

    ACCU-CHEK ® SMARTVIEW TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·December 10, 2012

    CATH PKGD: BERMAN 6 FR 90CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DYG·June 23, 2015

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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