BEUDAMED
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    SYSTEM 1000 SPDS

    FDA Adverse Event
    ALTHIN MEDICAL, INC.·Product code FKP·August 25, 1999

    NI

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·October 20, 2023

    HUMAPEN ERGO, BURG/CLEAR

    FDA Adverse Event
    Malfunction ·ELI LILLY AND CO.·Product code FMF·November 1, 2005

    SJM MECHANICAL HEART VALVE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, PUERTO RICO, INC. (CS)·Product code LWQ·September 16, 2011

    GLOOKO

    FDA Adverse Event
    Malfunction ·GLOOKO INC.·Product code PHV·October 15, 2024

    GLOOKO

    FDA Adverse Event
    Malfunction ·GLOOKO INC.·Product code PHV·October 15, 2024

    GLOOKO

    FDA Adverse Event
    Malfunction ·GLOOKO INC.·Product code PHV·October 15, 2024

    PORTICO TAVI VALVE, 27MM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, COSTA RICA LTDA·Product code NPT·December 14, 2021

    Vaginal PH Test

    FDA Enforcement
    Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

    HUMAPEN ERGO, TEAL/CLEAR

    FDA Adverse Event
    Malfunction ·ELI LILLY AND CO.·Product code KZE·November 8, 2005

    AXSYM HCV 3.0

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MZO·December 26, 2008

    AXSYM HCV 3.0

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MZO·December 26, 2008

    UNKNOWN MECHANICAL HEART VALVE

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code LWQ·March 15, 2024

    AXSYM HCV 3.0

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MZO·May 15, 2009

    AXSYM HCV 3.0

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MZO·January 9, 2009

    HLC-723G8

    FDA Adverse Event
    Malfunction ·TOSOH BIOSCIENCE, INC. (OHIO)·Product code PDJ·November 8, 2024

    CareLink Clinic, REF: MMT-7350

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code PHV·October 21, 2025

    CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.

    FDA Recall
    Terminated ·Medtronic Inc.·Product code PHV·August 5, 2016

    CARELINK PRO ONLINE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code PHV·May 20, 2022

    CARELINK WEB UPLOADER

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code PHV·April 14, 2022