BEUDAMED
    15 results · 29ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707085140·WEB I MOL BANDS G8424-17+G2820-00 LL 2

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756734080·CATH ANGIOGRAPHY DRAPE PACK

    MICRODEBRIDER 1898200T IGS M4

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·May 15, 2014

    MICRODEBRIDER 1898200T IGS M4

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ERL·May 10, 2013

    XPS® BLADE

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code EQJ·July 24, 2015

    XPS® HANDPIECE - MAGNUM® II

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ERL·May 3, 2016

    ITC & ITE HEARING AID, HEAR CLEAR MODELS 1-4

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    MODEL 2100 FETAL MONITOR

    FDA 510(k)

    IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·November 15, 2015

    Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183

    FDA Enforcement
    Class II ·Ongoing·DeRoyal Industries Inc·July 12, 2023

    RESTORE ADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 26, 2014

    FREESTYLE LITE

    FDA Adverse Event
    Malfunction ·Product code NBW·November 11, 2010

    DIGITAL RADIOGRAPHY CXDI-70C WIRELESS

    FDA Adverse Event
    Malfunction ·CANON, INC.·Product code MQB·December 31, 2012

    Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183

    FDA Recall
    Open, Classified ·DeRoyal Industries Inc·Product code OEQ·May 30, 2023