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

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    RAYSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564030597·Linen Pack, Heart w/ Gowns

    NOVO Health Services, LLC

    FDA UDI
    SRI Healthcare, LLC·00810019801969·Linen Pack, Heart w/ Gowns

    MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MYALLERGYTEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 25, 2020

    TREATMENT RECLINER

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FRK·May 20, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 10, 2011

    JAMSHIDI NEEDLE BONE MARROW 13GX3.5 ASP - DJ3513X

    FDA Adverse Event
    Injury ·CAREFUSION, INC·Product code KNW·December 21, 2021

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015