BEUDAMED
    27 results · 50ms · Sources: EU EUDAMED, US FDA

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    NA

    FDA Adverse Event
    Malfunction ·BEMIS MFG COMPANY·Product code KDQ·January 27, 2014

    MYO/WIRE

    FDA Adverse Event
    Death ·ALTO DEVELOPMENT CORP. D/B/A A& E MED CORP·Product code LDF·June 22, 2006

    ELECTRODE, CUTTING LOOP, 26FR

    FDA Adverse Event
    Malfunction ·RICHARD WOLF MEDICAL INSTRUMENTS CORP.·Product code FAS·July 27, 2015

    ELECTRODE, 22 FR CUTTING LOOP

    FDA Adverse Event
    Malfunction ·RICHARD WOLF MEDICAL INSTRUMENTS CORP.·Product code FAS·August 10, 2015

    ELECTRODE,22 FR CUTTING LOOP

    FDA Adverse Event
    Malfunction ·RICHARD WOLF MEDICAL INSTRUMENTS CORP.·Product code FAS·August 10, 2015

    ELECTRODE, CUTTING LOOP, 26FR

    FDA Adverse Event
    Malfunction ·RICHARD WOLF MEDICAL INSTRUMENTS CORP.·Product code FAS·July 27, 2015

    BILIARY DRAINAGE

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FGE·April 9, 2014

    Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·July 16, 2025

    KTR Europe GmbH

    Authorized representative
    🇩🇪 Germany·135 Manufacturers·3461 Devices

    Obelis s.a.

    Authorized representative
    🇧🇪 Belgium·546 Manufacturers·18515 Devices

    MDSS GmbH

    Authorized representative
    🇩🇪 Germany·388 Manufacturers·16562 Devices

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    CMC Medical Devices & Drugs SL

    Authorized representative
    🇪🇸 Spain·698 Manufacturers·11260 Devices

    36 QUAD-FURCATED SCIG SET 27GX9MM NEEDLES

    FDA Adverse Event
    Malfunction ·EMED CORP·Product code FPA·September 23, 2008

    Advena Limited

    Authorized representative
    🇲🇹 Malta·467 Manufacturers·13717 Devices

    Share info GmbH

    Authorized representative
    🇩🇪 Germany·154 Manufacturers·1206 Devices

    MedNet EC-REP GmbH

    Authorized representative
    🇩🇪 Germany·464 Manufacturers·5263 Devices

    Wellkang Ltd

    Authorized representative
    259 Manufacturers·3500 Devices

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 9, 2005

    RIOMAVIX LTD

    Authorized representative
    🇪🇸 Spain·400 Manufacturers·4531 Devices