BEUDAMED
    12 results · 38ms · Sources: EU EUDAMED, US FDA

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    IVY COMMANDER (MODEL 500)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556701352·GC Initial™ MC Enamel E-60, 250g

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228708201·GC Initial™ MC Enamel E-60, 250g

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC·Product code KWP·December 18, 2014

    ARCHITECT TACROLIMUS: MODEL 1L77

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Capnograph and Oximeter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ASR ACETABULAR CUPS 48

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 12, 2014

    OCTRODE 3/4 PERCUTANEOUS LEADS

    FDA Adverse Event
    Injury ·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·October 6, 2010

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPB·December 12, 2012

    ABBOTT TUBE EDTA PLH 13X75 2.0 PNK

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 3, 2022

    ABBOTT TUBE EDTA PLH 13X75 2.0 PNK

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·September 17, 2019

    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