BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    HI-TORQUE BALANCE TREK GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MIS Ti-base Abutment

    FDA 510(k)
    FDA Class 2 ·Dental

    VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INVISION-PLUS

    FDA Adverse Event
    Malfunction ·RYMED TECHNOLOGIES, LLC·Product code FPA·July 7, 2022

    ACCESSORIES

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code DQX·March 20, 2025

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 6, 2013

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·February 15, 2011

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·August 8, 2014

    INDEFLATOR

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code MAV·February 27, 2024

    INDEFLATOR

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code MAV·March 21, 2024

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45; c) PAED. TRACHEOSTOMY TUBE 5.0MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP50; d) PAED. TRACHEOSTOMY TUBE 5.5MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP55

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