BEUDAMED
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    200 MICRON TFL BALL TIP SINGLE USE FIBER

    FDA Adverse Event
    Malfunction ·GYRUS ACMI, INC.·Product code GEX·May 24, 2023

    LOFRIC DILACATH

    FDA Adverse Event
    Injury ·WELLSPECT HEALTHCARE·Product code FBX·June 14, 2013

    DDV LIGATOR URETHRAL SOUND

    FDA Adverse Event
    Malfunction ·NORTH AMERICAN MEDICAL, INC.·Product code FBX·November 14, 1994

    GRIP-TIP URETHRAL SUTURE GUIDE

    FDA Adverse Event
    Malfunction ·GREENWALD SURGICAL CO., INC.·Product code FBX·May 16, 1997

    BARD® GOODWIN SOUND

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code FBX·August 9, 2021

    BARD® GOODWIN SOUND

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code FBX·September 10, 2021

    BARD® GOODWIN SOUND

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code FBX·August 8, 2021

    GRIP-TIP URETHRAL SUTURE GUIDE

    FDA Adverse Event
    Malfunction ·GREENWALD SURGICAL CO, INC·Product code FBX·March 4, 2005

    BARD® GOODWIN SOUND

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code FBX·February 28, 2022

    LEFORT URETHRAL SOUND 24 FR.

    FDA Adverse Event
    Malfunction ·ALLEGIANCE HEALTHCARE CORP.·Product code FBX·November 5, 1998

    BARD® GOODWIN SOUND

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code FBX·March 1, 2022

    FEMALE CATHETR 5-3/4 14FR

    FDA Adverse Event
    Injury ·INTEGRA - MILTEX·Product code FBX·April 10, 2017

    BARD® GOODWIN SOUND

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code FBX·March 1, 2022

    BARD® GOODWIN SOUND

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code FBX·February 28, 2022

    BARD® GOODWIN SOUND

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code FBX·March 2, 2022

    BARD® GOODWIN SOUND

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code FBX·March 1, 2022

    BARD® GOODWIN SOUND

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code FBX·March 1, 2022

    ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code FBX·December 3, 2024

    Sound, Urethral, Metal Or Plastic

    FDA classification
    FDA Class 1 ·Sound, Urethral, Metal Or Plastic

    OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·June 18, 2025