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

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    ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ARCOS INTERLOCKING DISTAL STEMS

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    VIDAS CA 15-3 ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACCU-CHEK ® INSIGHT FLEX

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE, INC.·Product code FPA·January 31, 2018

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 11, 2025

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 25, 2019

    MICRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code PNJ·January 25, 2019

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 27, 2011

    ANGIODYNAMICS SOFT-VU OMNI FLUSH

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS, INCORPORATED·Product code MSD·September 29, 2008

    Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d) 5.5MM FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e) 6.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS60

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

    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017