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

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    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065760·INTRAORAL ELASTICS 6,5 oz 3/8" orange

    ATLAS SPINE SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489125563·PowerChem Neoprene Exam Gloves, Extra Extra Large

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065739·INTRAORAL ELASTICS 6,5 oz 3/16" green

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065746·INTRAORAL ELASTICS 6,5 oz 1/4" red

    HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SPINAL MESH SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PYRAMESH C TITANIUM MESH

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code EZX·August 12, 2011

    PYRAMESH

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code EZX·September 29, 2015

    ASTERX EXPANDABLE CORPECTOMY SYSTEM

    FDA Adverse Event
    Injury ·MSD DEGGENDORF MFG·Product code MQP·March 4, 2019

    ASTERX EXPANDABLE CORPECTOMY SYSTEM

    FDA Adverse Event
    Injury ·MSD DEGGENDORF MFG·Product code MQP·March 4, 2019

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Recall
    Terminated ·Optovue Inc.·Product code OBO·September 7, 2012

    PYRAMESH C TITANIUM MESH

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code EZX·October 26, 2019

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Enforcement
    Class II ·Terminated·Optovue Inc.·October 31, 2012

    PANORAMA CENTRAL STATION

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    *

    FDA Adverse Event
    Malfunction ·MEDICAL ACTION INDUSTRIES, INC.·Product code FSM·August 26, 2014

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FPO·May 5, 2011

    UNKNOWN HIP FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·October 14, 2019

    UNKNOWN HIP ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·October 14, 2019

    UNKNOWN HIP FEMORAL STEM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·October 14, 2019