BEUDAMED
    20 results · 27ms · Sources: EU EUDAMED, US FDA

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    Clarius Ultrasound Scanner

    FDA 510(k)
    FDA Class 2 ·Radiology

    CLARIUS ULTRASOUND SCANNER

    FDA Adverse Event
    Malfunction ·CLARIUS MOBILE HEALTH CORP.·Product code IYN·October 17, 2024

    ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NORMATEC PCD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GLP TRACK END

    FDA Adverse Event
    Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·May 18, 2026

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 25, 2014

    ASR ACETABULAR CUPS 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 9, 2013

    GLP CENTRIFUGE MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·July 10, 2025

    GLP CENTRIFUGE MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·December 27, 2024

    GLP CENTRIFUGE MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·April 28, 2025

    GLP ALIQUOT MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·August 1, 2025

    GLP TRACK END

    FDA Adverse Event
    Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·April 1, 2026

    GLP TRACK END

    FDA Adverse Event
    Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·November 14, 2024

    GLP CENTRIFUGE MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·December 27, 2024

    GLP CENTRIFUGE MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·June 19, 2025

    GLP BULK LOADER MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·May 12, 2025

    LAPIPLASTY 4.0MM FULLY THREADED SCREW

    FDA Adverse Event
    Injury ·TREACE MEDICAL CONCEPTS, INC.·Product code HWC·March 14, 2025

    GLP LOADER MODULE

    FDA Adverse Event
    Injury ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·May 5, 2025

    Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026