BEUDAMED
    94 results · 57ms · Sources: EU EUDAMED, US FDA

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    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MRU·August 18, 2021

    PULSE GEN MODEL 102R

    FDA Adverse Event
    Death ·LIVANOVA USA, INC.·Product code LYJ·December 22, 2021

    MedEnvoy Global BV

    Authorized representative
    🇳🇱 Netherlands·143 Manufacturers·2306 Devices

    BARRX 360

    FDA Adverse Event
    Injury ·COVIDIEN LP BARRX·Product code GEI·February 1, 2023

    UNKNOWN BARRX

    FDA Adverse Event
    Injury ·COVIDIEN LP BARRX·Product code GEI·February 1, 2023

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·July 8, 2019

    1.5T LINX, 14B

    FDA Adverse Event
    Injury ·TORAX MEDICAL, INC.·Product code LEI·August 23, 2022

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDS·May 11, 2020

    DISPOSABLE DISTAL ATTACHMENT

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDS·May 11, 2020

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDS·May 11, 2020

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·June 14, 2022

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·December 1, 2017

    Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled with the foot pedal; (3) Foot Pedal; and (4) CryoBalloon Cartridge containing 36 grams of nitrous oxide.

    FDA Enforcement
    Class II ·Terminated·PENTAX of America Inc·May 22, 2019

    BIOTENE DRY MOUTH ORAL RINSE

    FDA Adverse Event
    Other ·GLAXOSMITHKLINE·Product code LFD·March 14, 2014

    Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled with the foot pedal; (3) Foot Pedal; and (4) CryoBalloon Cartridge containing 36 grams of nitrous oxide.

    FDA Enforcement
    Class II ·Terminated·PENTAX of America Inc·May 22, 2019

    Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled with the foot pedal; (3) Foot Pedal; and (4) CryoBalloon Cartridge containing 36 grams of nitrous oxide.

    FDA Enforcement
    Class II ·Terminated·PENTAX of America Inc·May 22, 2019

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·November 18, 2011

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·May 10, 2019

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·August 13, 2019

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·November 23, 2017