BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    COBAS READY LDH REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Excel Plus

    FDA UDI
    A. R. DAVIS COMPANY, INC.·00861039000351·2" x 4" Oval Electrode

    ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·July 17, 2024

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756665537·TOTAL JOINT ORTHO MAJOR PGYBK

    FETAL HEMOGLOBIN

    FDA 510(k)
    FDA Class 2 ·Hematology

    ABBOTT SPECTRUM AMYLASE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 26, 2014

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·December 5, 2012

    QUICK FLEX LV LEAD

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·November 10, 2010

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015