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

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    VACLOK SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    QUIDEL FOOD ALLERGEN SCREEN

    FDA 510(k)
    FDA Class 2 ·Immunology

    ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY

    FDA 510(k)
    FDA Class 2 ·Hematology

    CAREFUSION ALARIS PUMP

    FDA Adverse Event
    Injury ·CAREFUSION·Product code FPA·February 28, 2013

    CATH-LAB SHEATH INTRO SE T:

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code DYB·January 14, 2011

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·July 23, 2014

    LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

    FDA Recall
    Terminated ·Zest Anchors LLC·Product code DZE·January 16, 2014

    LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

    FDA Enforcement
    Class II ·Terminated·Zest Anchors LLC·February 12, 2014

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026