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

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    DISPOSABLE PLASTIC VAGINAL SPECULA

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

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756622134·EYE TRAY

    AUSTENAL DENTAL COMPOSITE RESIN

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ENDURON 10D 56 OR 68ODX28ID

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code JDI·June 25, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 3, 2013

    ACCURUS 800CS

    FDA Adverse Event
    Injury ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·November 5, 2010

    SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·November 20, 2013

    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