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    Hearing Help Express

    FDA UDI
    INTRICON CORPORATION·00858177007335·Android App

    Hearing Help Express

    FDA UDI
    INTRICON CORPORATION·00858177007113·iOS App

    HHE Arm Blood Pressure Monitor

    FDA UDI
    Alicn Medical Shenzhen, Inc.·06953775601085·

    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·March 19, 2025

    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/A

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·February 26, 2025

    OPTIMA COIL SYSTEM

    FDA Adverse Event
    Malfunction ·BALT USA·Product code HCG·January 28, 2022

    Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

    FDA Enforcement
    Class I ·Ongoing·Datascope Corp.·September 6, 2023

    MRIDIUIM 1000 SERIES INFUSION SETS

    FDA Adverse Event
    Malfunction ·IRADIMED CORPORATION·Product code FPK·March 21, 2023

    TITAN INFLATABLE PENILE PROSTHESIS FAMILY

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code FHW·September 23, 2025

    MRIDIUM SERIES 1000 INFUSION SETS

    FDA Adverse Event
    Malfunction ·IRADIMED CORPORATION·Product code FPK·March 21, 2023

    MRIDIUM SERIES 1000 INFUSION SETS

    FDA Adverse Event
    Malfunction ·IRADIMED CORPORATION·Product code FPK·March 21, 2023

    MRIDIUM 1000 SERIES INFUSION SET

    FDA Adverse Event
    Malfunction ·IRADIMED CORPORATION·Product code FPK·March 21, 2023

    MRIDIIUM SERIES 1000 INFUSION SET

    FDA Adverse Event
    Malfunction ·IRADIMED CORPORATION·Product code FPK·March 21, 2023

    STAT2® PUMPETTE IV GRAVITY FLOW COMPENSATING CONTROLLER-20 DROPS/ML

    FDA Adverse Event
    Malfunction ·CONMED CORPORATION·Product code FPA·May 9, 2011

    COR/TRI ANT STEM INSERT SHAFT

    FDA Adverse Event
    Malfunction ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LXH·December 12, 2013

    PHILIPS M2735A SMART TOCO + TRANSDUCER

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH·Product code HGM·October 20, 2019

    PHILIPS M1356A US BELT/WIRE KNOB

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH·Product code HGM·November 11, 2019

    PHILIPS M2736A AVALON U/S TRANSDUCER

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH·Product code HGM·November 7, 2019

    PHILIPS M2736A AVALON U/S TRANSDUCER

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH·Product code HGM·November 8, 2019

    PHILIPS M2734B SMART TOCO TRANSDUCER

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH·Product code HGM·October 20, 2019