BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FS ACTIVATOR III

    FDA 510(k)
    FDA Unclassified ·Unknown

    TCM ENDO III

    FDA 510(k)
    FDA Class 1 ·Dental

    UNKNOWN

    FDA Adverse Event
    WILLIAM COOK EUROPE·Product code DTK·October 27, 2015

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 17, 2025

    TEXIUM CLOSED MALE LUER WITH FEMALE CAP

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP·Product code FPA·March 27, 2013

    MINIBORE EXT SET 60IN NDEHP

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·March 22, 2011

    EZ STEER DS BI-DIRECTIONAL NAVIGATIONAL DIAGNOSTIC/ABLATION

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·June 20, 2008

    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001635;

    FDA Enforcement
    Class II ·Ongoing·Beaver Visitec International, Inc.·September 4, 2024

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55

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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015