BEUDAMED
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    THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Hader

    FDA UDI
    Preat Corporation·00842092175477·Hader Alignment Combo Kit. Kit contains. 2 Hade...

    LIEBERMAN SPECULUM

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896072213·LIEBERMAN SPECULUM TEMPORAL APPROACH CURVED BLA...

    Spark TruColor

    FDA UDI
    METREX RESEARCH, LLC·00615375013243·FINAL ASSEMBLY, SPARK™ TRUCOLOR, TTL, NORTH AME...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450267066·

    EXACTECH GPS

    FDA 510(k)
    FDA Class 2 ·Neurology

    RESUSCI INFLATE-A-SHIELD CPR BARRIER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 30, 2013

    FMS - FECAL MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·CONVATEC INC·Product code KNT·September 15, 2014

    CARESCAPE MONITOR B850

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MHX·May 10, 2011

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·March 30, 2023

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·March 30, 2023

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·March 30, 2023

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·March 30, 2023

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·March 30, 2023

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·March 30, 2023

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·September 17, 2025

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025

    Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·November 1, 2023