BEUDAMED
    31 results · 26ms · Sources: EU EUDAMED, US FDA

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    REAGENTS FOR DETERM. SERUM IRON IN HUMAN

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACUMED

    FDA UDI
    Acumed LLC·10806378043987·Elbow System Olecranon-Coronoid Platter

    COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE

    FDA 510(k)
    FDA Class 1 ·Dental

    ZUMA GUIDE CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 8, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 22, 2012

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code NBW·September 7, 2007

    ZUMA Z2 7F GUIDE CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC·Product code DQY·June 12, 2020

    MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJQ·October 3, 2022

    MicroScan WalkAway-40 plus Instrument REF B1018-283

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code LRG·October 21, 2019

    MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code LRG·October 21, 2019

    MicroScan WalkAway-96 plus Instrument REF B1018-284

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code LRG·October 21, 2019

    DxM 1040 MicroScan WalkAway Instrument REF B1018-440

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code LRG·October 21, 2019

    DxM 1096 MicroScan WalkAway Instrument REF B1018-496

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code LRG·October 21, 2019

    MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code LRG·October 21, 2019

    MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code LTT·September 10, 2015

    MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code LTT·September 10, 2015

    MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST).

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code OUG·July 17, 2015

    MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code OUG·October 25, 2016

    MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code LTT·July 24, 2025