BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    Estelite Universal Flow

    FDA 510(k)
    FDA Class 2 ·Dental

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486000769·MCK Onlay Tibia Baseplate

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306821653·Kirby Muscle Hook Expressor 6" Double Ended

    BIOMED WOUND CLEANSER

    FDA 510(k)
    FDA Unclassified ·Unknown

    CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045

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

    TENDRIL SDX

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·June 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·October 17, 2014

    UNKNOWN_SIZE 3 PKA INSERT

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code NPJ·January 17, 2022

    BD MAX¿ CPO

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·May 13, 2025

    BD MAX¿ CPO

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 21, 2025

    VIDAS® TOXO IGG II

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, SA·Product code LGD·February 16, 2018

    Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·March 9, 2016