BEUDAMED
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    SOLE SUPPORTS, INC

    FDA registration
    SOLE SUPPORTS, INC·1 product·🇺🇸 United States

    Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830

    FDA Recall
    Terminated ·Product code ITJ·March 6, 2020

    AXILLARY INSERTION KIT

    FDA Adverse Event
    Malfunction ·ABIOMED, INC. - 1220648·Product code DYB·March 5, 2026

    PURGE CASSETTE GEN 2, STERILE, NON QSK

    FDA Adverse Event
    Malfunction ·ABIOMED, INC. - 1220648·Product code OZD·March 6, 2026

    DAVINCI XI

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·March 6, 2025

    NONE

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code GCJ·April 18, 2023

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·January 19, 2012

    IMPELLA CONTROLLER, PACKAGED, US

    FDA Adverse Event
    Malfunction ·ABIOMED, INC. - 1220648·Product code OZD·March 6, 2026

    Elevate System with IntePro Lite", Anterior and Apical Prolapse Repair System, REF720093-01, Sterile EO, Manufactured by:American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA Product Usage: The AMS Elevate System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenteriological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair. As configured, the Elevate Anterior device is used solely for prolapse repair

    FDA Recall
    Terminated ·American Medical Systems, Inc.·Product code FTL·May 9, 2011

    TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

    FDA Adverse Event
    Death ·ABIOMED, INC. - 1220648·Product code OZD·April 14, 2026

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·May 11, 2026

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·May 27, 2026

    DAVINCI XI

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·January 30, 2023

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 14, 2013

    Mammotome MammoStar Biopsy Site Identified, REF STAR1401

    FDA Recall
    Terminated ·Carbon Medical Technologies, Inc.·Product code NEU·December 16, 2022

    DAVINCI XI

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·October 1, 2024

    UNKNOWN CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBES

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code KNT·April 7, 2025

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·May 10, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NALL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 7, 2022

    MESH SOFRADIM - URETEX

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION SAS·Product code OTN·August 17, 2017