BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    Monkey Bars Pin to Bar External Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NobelProcera Zirconia Implant Bridge

    FDA 510(k)
    FDA Class 2 ·Dental

    RIVA SILVER

    FDA 510(k)
    FDA Class 2 ·Dental

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    HEMOSPHERE ALTA

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025

    HEMOSPHERE ALTA

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code QAQ·August 20, 2025

    HEMOSPHERE ALTA

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·November 11, 2014

    ATLAS PLUS VR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2011

    CAPSURE EPI

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code NVN·July 23, 2013

    HEMOSPHERE ALTA

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025

    BENCHMARK SPECIAL STAINS SYSTEM

    FDA Adverse Event
    Injury ·VENTANA MEDICAL SYSTEMS INC.·Product code KPA·August 21, 2025

    PKG, 5MM INSERT, 45CM, DEBAKEY FORCEPS, P/N 0250080748 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84, ZIMB-26-98, ZIMB-28-108, ZIMB-28-118, ZIMB-28-128, ZIMB-28-70, ZIMB-28-84, ZIMB-28-98, ZIMB-30-108, ZIMB-30-118, ZIMB-30-128, ZIMB-30-70, ZIMB-30-84, ZIMB-30-98, ZIMB-32-108, ZIMB-32-118, ZIMB-32-128, ZIMB-32-70, ZIMB-32-84, ZIMB-32-98, ZIMB-36-108, ZIMB-36-118, ZIMB-36-128, ZIMB-36-70, ZIMB-36-84, ZIMB-36-98

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 26, 2019