BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ISOROD PD-103 IMPLANT, MODEL ATI-PD-103

    FDA 510(k)
    FDA Class 2 ·Radiology

    INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MICROLET®

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code QRL·April 23, 2026

    MICROLET®

    FDA Adverse Event
    Injury ·ASCENSIA DIABETES CARE US INC.·Product code QRL·April 3, 2025

    STRYKER PAIN PUMP 2 BLOCK AID

    FDA Adverse Event
    Malfunction ·STRYKER·Product code MEA·November 3, 2008

    KANGAROO EPUMP - NEW

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code LZH·June 25, 2013

    PROLIEVE THERMODILITATION SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MEQ·August 23, 2011

    MICROLET®

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code QRL·July 1, 2025

    MICROLET®

    FDA Adverse Event
    Injury ·ASCENSIA DIABETES CARE US INC.·Product code QRL·December 1, 2023

    INSPIRE 7F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA SRL·Product code DTZ·September 15, 2022

    INSPIRE 7F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL.·Product code DTZ·March 12, 2024

    INSPIRE 7F

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·June 24, 2025

    INSPIRE 7F

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·February 5, 2025

    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

    FDA Enforcement
    Class II ·Terminated·Unomedical As·July 1, 2015

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025