BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    PERCOR DATASCOPE INTRA-AORTIC BALLOON

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450180280·

    KARMAN WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX

    FDA 510(k)
    FDA Class 2 ·Dental

    SMR SHOULDER

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·May 21, 2019

    RESERVOIR 1.8 ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 23, 2012

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·August 24, 2007

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 30, 2013

    GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024