BEUDAMED
    9 results · 23ms · Sources: EU EUDAMED, US FDA

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    SLIDE CULTURE PLATE-POTATO FLAKE AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    TECHNICON BGII ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ORTHOTIC LEG GAIT CORRECTOR DEVICE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·March 4, 2025

    MONOMAX VIOLET 1(4) 150CM HRN50 LOOP (M)

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL S.A.·Product code NWJ·May 28, 2014

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code JJE·October 25, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 20, 2012

    Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024