BEUDAMED
    22 results · 25ms · Sources: EU EUDAMED, US FDA

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    JAMSHIDI MARROW ACQUISITION CRADLE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092102954·CAMLOG® Screw-Line-compatible 3.8mm Esthetic Ab...

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099822·MX 1/2 BI BD KT N/L R/L 170

    ETHIBOND EXCEL VALVE LOOP SUTURE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCUSONIC PLUS, MODEL AP-100

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    NA

    FDA UDI
    Zimmer, Inc.·00889024066588·

    MIO

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·September 17, 2024

    FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTO·February 28, 2013

    EXTENSION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·March 1, 2011

    ECHO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·February 28, 2008

    TRELLIFORM

    FDA Adverse Event
    Injury ·DSM BIOMEDICAL, INC.·Product code FTM·April 16, 2020

    iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·January 31, 2024

    PIPELINE FLEX EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·April 25, 2024

    PIPELINE FLEX EMBOLIZATION DEVICE

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·April 25, 2024

    iQ200 Series Urine Microscopy Analyzer- All part numbers

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·May 20, 2020

    iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·February 5, 2020

    BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KQO·March 2, 2018

    BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·April 18, 2018

    iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code LKM·December 19, 2023

    smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024