BEUDAMED
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    INFILTRATION PUMP SYRINGE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RICO RS-6X EMERGENCY MEDICAL ASPIRATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT

    FDA 510(k)
    FDA Class 2 ·Dental

    SUMMIT BASIC CEMENTED SZ 2

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043·Product code JDI·June 25, 2014

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·January 3, 2013

    ADVIA 2400

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JGS·November 5, 2010

    ALARIS PUMP MODULE SET NON-VENTED BLOOD SET

    FDA Adverse Event
    Malfunction ·Product code FPA·June 29, 2021

    BD ALARIS¿ LVP BLD180M 15D SS

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 30, 2020

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

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