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

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    LINSCAN 808, LINSCAN 980

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

    SLEEVE WITH ZIPLOOP FIXATION DEVICES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SMARTWAVE MS 2000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·August 26, 2019

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 6, 2019

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·June 3, 2013

    HENRY SCHEIN SOFTLINE CHAIRSIDE RELINE KIT

    FDA Adverse Event
    Other ·SEPTODONT CONFI-DENTAL DIVISION·Product code EBC·June 15, 2011

    BARD CWS 400 CLOSED WOUND SUCTION KIT

    FDA Adverse Event
    Injury ·C.R. BARD, INC.·Product code GCY·August 29, 2008

    EQUINOXE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·January 9, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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