BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    PLAC TEST FOR LP-PLA2 ACTIVITY

    FDA 510(k)
    FDA Class 2 ·Immunology

    SSW CARBIDE

    FDA UDI
    Ss White Burs, Inc.·D6901415752·RA SL CARBIDE 557 - 5 PACK

    FENZIAN TREATMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·August 5, 2019

    EQUINOXE

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

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 5, 2019

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 4, 2014

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2013

    STAR TOTAL ANKLE REPLACEMENT

    FDA Adverse Event
    Injury ·WALDEMAR LINK, GMBH & CO.·Product code HSN·June 16, 2011

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 7, 2025

    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