BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    HYDROTONE-THERMAL CAPSULE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    412 P37,R3,1L,RAD,SPECIAL WIRING,STKR

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828100915·412 P37,R3,1L,RAD,SPECIAL WIRING,STKR

    ImmuView S pneumoniae and L pneumophila Urinary Antigen Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BIOBRANE BRAND TEMPORARY WOUND DRESSING

    FDA 510(k)

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 6, 2013

    ANGIOSCULPT PTA SCORING BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·ANGIOSCORE, INC.·Product code LIT·January 28, 2011

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·August 8, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

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