BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    JMS Harmony A.V. Fistula Needle Set

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

    AGXO

    FDA UDI
    Oticon A/S·05707131283559·H100V2, BTE 13 WL 85 DBL AGXO

    AGC Tradition Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304008236·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694040693·PrimaLIF LLIF 17mm x 18mm Lordotic Trial

    VARIANT

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030SPO1510170·Threaded Fixation Pin, ø3mm x 170mm

    CYBERWAND PROBE

    FDA Adverse Event
    Malfunction ·CYBERSONICS INC.·Product code FFK·December 28, 2017

    ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    R-X-FIX EXTERNAL FIXATOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 12, 2025

    VANTAGE ANKLE COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code HSN·November 5, 2024

    PK DISSECTING FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 6, 2013

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·June 21, 2011

    VITROS 250 CHEMISTRY SYSTEM-REMANUFACTURED

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·August 28, 2008

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 2014

    Medical Linear Accelerator

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 14, 2016

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035; d) 4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040; e) 2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025; f) 3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030; g) 3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035; h) 4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040; i) 4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045; j) 5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050; k) 5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055

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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018