BEUDAMED
    182 results · 41ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    Bolder Surgical

    Manufacturer
    🇺🇸 United States·1 Importer

    BOLDER SURGICAL, LLC

    FDA registration
    BOLDER SURGICAL, LLC·3 products·🇺🇸 United States

    BOLDER SURGICAL JUSTRIGHT STAPLER 5MM

    FDA Adverse Event
    Injury ·BOLDER SURGICAL LLC·Product code GAG·July 21, 2021

    COOLSEAL GENERATOR

    FDA Adverse Event
    Malfunction ·BOLDER SURGICAL·Product code GEI·February 1, 2022

    JUSTRIGHT 5MM STAPLER

    FDA Adverse Event
    Injury ·BOLDER SURGICAL·Product code GAG·March 23, 2021

    JUSTRIGHT 5MM STAPLER

    FDA Adverse Event
    Malfunction ·BOLDER SURGICAL·Product code GAG·June 9, 2021

    JUSTRIGHT 5MM STAPLER

    FDA Adverse Event
    Injury ·BOLDER SURGICAL·Product code GAG·June 10, 2021

    JUSTRIGHT 5MM STAPLER

    FDA Adverse Event
    Injury ·BOLDER SURGICAL·Product code GAG·June 10, 2021

    COOLSEAL TRINITY

    FDA Adverse Event
    Malfunction ·BOLDER SURGICAL·Product code GEI·April 30, 2021

    COOLSEAL¿ TRINITY

    FDA Adverse Event
    Injury ·BOLDER SURGICAL·Product code GEI·June 14, 2022

    COOLSEAL¿ TRINITY

    FDA Adverse Event
    Malfunction ·BOLDER SURGICAL·Product code GEI·June 14, 2022

    COOLSEAL¿ TRINITY

    FDA Adverse Event
    Injury ·BOLDER SURGICAL·Product code GEI·June 14, 2022

    COOLSEAL¿ TRINITY

    FDA Adverse Event
    Malfunction ·BOLDER SURGICAL·Product code GEI·June 14, 2022

    JUSTRIGHT 5MM STAPLER

    FDA Adverse Event
    Malfunction ·BOLDER SURGICAL·Product code GAG·December 20, 2021

    JUSTRIGHT 5MM STAPLER

    FDA Adverse Event
    Injury ·BOLDER SURGICAL·Product code GAG·June 7, 2022

    JUSTRIGHT¿ STAPLER 5 MM

    FDA Adverse Event
    Injury ·BOLDER SURGICAL·Product code GAG·September 25, 2024

    JUSTRIGHT¿ STAPLER 5 MM

    FDA Adverse Event
    Injury ·BOLDER SURGICAL·Product code GAG·September 25, 2024

    JUSTRIGHT¿ STAPLER 5 MM

    FDA Adverse Event
    Injury ·BOLDER SURGICAL·Product code GAG·September 25, 2024

    COOLSEAL¿ REVEAL

    FDA Adverse Event
    Injury ·BOLDER SURGICAL·Product code GEI·July 22, 2024

    JUSTRIGHT¿ STAPLER 5 MM

    FDA Adverse Event
    Injury ·BOLDER SURGICAL·Product code GAG·September 25, 2024