BEUDAMED
    193 results · 15ms · Sources: EU EUDAMED, US FDA

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    A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code MHY·March 9, 2021

    wDR 2.2 Mobile Digital Diagnostic X-Ray System

    FDA Recall
    Open, Classified ·SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain·Product code IZL·May 23, 2023

    EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic

    FDA Recall
    Open, Classified ·Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden·Product code MOB·May 24, 2023

    DigitalDiagnost C90, Model No. 712034 and 712035

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MQB·May 19, 2023

    Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.

    FDA Recall
    Open, Classified ·CHANGE HEALTHCARE CANADA COMPANY·Product code LLZ·November 1, 2023

    Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system

    FDA Recall
    Open, Classified ·Medtronic MiniMed·Product code MDS·November 21, 2022

    Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease Material Number 12410002

    FDA Recall
    Open, Classified ·Phadia US Inc·Product code MST·May 1, 2023

    1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platforms for supporting LVAD patients. Along with being able to program and monitor the LVAS, the HeartMate Touch Application introduces features that enables users to setup pairing and connection with the existing HeartMate 3 Left Ventricular Assist System (LVAS) via the HeartMate Touch Wireless Adapter and generate reports from the log files that are downloaded from the HM3 System Controller.

    FDA Recall
    Open, Classified ·Thoratec Corp.·Product code DSQ·January 3, 2024

    EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease Material Number 14553901

    FDA Recall
    Open, Classified ·Phadia US Inc·Product code MST·May 1, 2023

    Temporary Titanium Abutments

    FDA Recall
    Open, Classified ·DDS Lab·Product code NHA·December 6, 2024

    BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code MDB·October 31, 2024

    BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JQP·October 31, 2024

    BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JQP·October 31, 2024

    BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code MDB·October 31, 2024

    BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JQP·October 31, 2024

    BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code QEP·October 31, 2024

    BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code MDB·October 31, 2024

    BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code QEP·October 31, 2024

    BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JQP·October 31, 2024

    BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code MDB·October 31, 2024