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

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    Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh

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

    NOFACT IX

    FDA 510(k)
    FDA Class 2 ·Hematology

    RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code FDX·February 22, 2021

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·June 3, 2013

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 23, 2014

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·June 20, 2011

    PKG, ALLIS FORCEPS, P/N 0250080240. 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

    FUSION CYTOLOGY BRUSH

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code FDX·January 6, 2022

    FUSION CYTOLOGY BRUSH

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code FDX·October 25, 2021

    CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

    FDA Adverse Event
    Injury ·WILSON-COOK MEDICAL INC·Product code FDX·May 4, 2022

    CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

    FDA Adverse Event
    Injury ·WILSON-COOK MEDICAL INC·Product code FDX·November 14, 2022

    CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code FDX·August 27, 2024

    FUSION CYTOLOGY BRUSH

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code FDX·July 31, 2024

    CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code FDX·May 28, 2024

    CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

    FDA Adverse Event
    Injury ·WILSON-COOK MEDICAL INC·Product code FDX·May 31, 2024

    CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code FDX·September 14, 2021

    FUSION CYTOLOGY BRUSH

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code FDX·November 12, 2024

    CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code FDX·January 13, 2025

    CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code FDX·November 18, 2022