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

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    MSI HEMATOLOGY CONTROL +

    FDA 510(k)
    FDA Class 2 ·Hematology

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228710671·GC Initial™ LF Enamel E-57, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556705381·GC Initial™ LF Enamel E-57, 20g

    INVISION Total Ankle Revision System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BACTRACK LCD ALCOHOL DETECTOR

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    OT PING ENHANCED METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 13, 2014

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 12, 2010

    UNKNOWN DEPUY ASR FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KXA·December 12, 2012

    INVISION¿ TOTAL ANKLE SYSTEM

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·July 18, 2022

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS40

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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