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

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    ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK

    FDA 510(k)
    FDA Class 2 ·Immunology

    SYNGO, CT DUAL ENERGY

    FDA 510(k)
    FDA Class 2 ·Radiology

    PERFORMANCE WATER TREATMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RENAISSANCE 26 P-WASS 10/04

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·January 29, 2013

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 17, 2010

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 15, 2014

    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