BEUDAMED
    11 results · 8ms · Sources: EU EUDAMED, US FDA

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    Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038

    FDA Enforcement
    Class II ·Completed·ESAOTE S.P.A.·March 11, 2026

    i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448

    FDA Enforcement
    Class II ·Terminated·HEALTH ROBOTICS S.R.L.·January 18, 2017

    ORCHESTRA/ORCHESTRA PLUS Programmer

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia S.r.l.·January 29, 2014

    MyLab Seven, Model 6400

    FDA Enforcement
    Class II ·Terminated·ESAOTE S.P.A.·October 31, 2018

    MyLab Gamma, Model 7410

    FDA Enforcement
    Class II ·Terminated·ESAOTE S.P.A.·October 31, 2018

    MyLab Alpha, Model 7400

    FDA Enforcement
    Class II ·Terminated·ESAOTE S.P.A.·October 31, 2018

    Alinity c Iron Reagent, Reference Number 08P3920

    FDA Enforcement
    Class II ·Ongoing·Sentinel CH SpA·November 29, 2023

    TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system. The system is a metal bone fixation device for stabilization and correction during the normal healing process. The purpose of the TL-HEX System is to provide a solution for deformity correction and keeping the bone segments aligned during the healing process. The device may only be applied by a physician, who is fully responsible for the surgical and post-operative procedures of the system and is able to manage possible mechanical and software limitations. Indications for use for adults and all pediatric subgroups except newborns include: post-traumatic joint contracture which has resulted in loss of range of motion, fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction, open and closed fracture fixation, pseudoarthrosis of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, correction of bony of soft tissue defects, joint arthrodesis, infected fractures or non unions.

    FDA Enforcement
    Class II ·Terminated·Orthofix Srl·June 13, 2018

    IRON assay, Reference Numbers 6K95-41 and 6K95-30

    FDA Enforcement
    Class II ·Ongoing·Sentinel CH SpA·November 29, 2023

    Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434

    FDA Enforcement
    Class II ·Ongoing·Medicalplastic S.R.L.·November 24, 2021

    SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02

    FDA Enforcement
    Class II ·Ongoing·Micromed S.p.A.·June 17, 2026