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

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    ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304

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

    M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COVER, BURR HOLE

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code GXR·July 1, 2016

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·October 11, 2021

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 8, 2013

    INSIGNIA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 6, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·September 22, 2016

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015