BEUDAMED
    15 results · 29ms · Sources: EU EUDAMED, US FDA

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    BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·May 11, 2015

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 21, 2015

    PENTACAM SCHEIMPFLUG CAMERA

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TVC IMAGING SYSTEM, TVC INSIGHT CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACTIVA

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·August 6, 2015

    ACTIVA

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·August 6, 2015

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·February 12, 2015

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 6, 2014

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    FDA Adverse Event
    Injury ·ALCON - FORT WORTH/ALCON LABORATORIES, INC.·Product code LPO·August 17, 2011

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD.·Product code MCM·July 17, 2013

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·August 2, 2023

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 22, 2013

    SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 4, 2024

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024