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

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    SBDX MOBILE FLUOROSCOPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127024344·Spring Loaded Calcar Planer

    ADAPTER NUT

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·March 15, 2011

    CGA-112 COPING GOLD ALLOY

    FDA 510(k)
    FDA Class 2 ·Dental

    TD TRICYCLIC ANTIDEPRESSANTS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ELECTRODE, PACEMAKER, PERMANENT

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·February 9, 2013

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 7, 2011

    PULSE GEN MODEL 102R

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·July 23, 2014

    Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" Used for the temporary relief of joint and muscle pain.

    FDA Enforcement
    Class II ·Terminated·Battle Creek Equipment Co.·November 9, 2016