BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SET, ADMINISTRATION, INTRAVASCULAR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 6, 2016

    QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Immunology

    AUTOMED 3000 INFUSION PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BLEASESIRUS

    FDA Adverse Event
    Malfunction ·SPACELABS MEDICAL, INC·Product code CBK·March 4, 2013

    GYNECARE GYNEMESH* PS

    FDA Adverse Event
    Injury ·ETHICON·Product code FTL·June 14, 2011

    SYNERGY VERSITREL

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·August 15, 2008

    K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080-18T; K-Wire Non-Threaded 1.4mm x 18, Part Number 9080-18U; 1.4mm x 24 Threaded Guide Wire, Part Number 9080-24T; K-Wire Non-Threaded 24, Part Number 9080-24U; Blunt K-Wire, 18 inches, Threaded, Part Number 9080B-18T; Blunt K-Wire, 18 inches, Unthreaded, Part Number 9080B-18U; Blunt K-Wire, 24 inches, Unthreaded, Part Number 9080B-24U; 1.4mm x 18 Blunt Threaded Nitinol Guide Wire, Part Number 9080B-N-18T; 1.4mm x 18" Blunt Non-Threaded Nitinol Guide Wire, Part Number 9080B-N-18U; Lodestar K-wire Non-Threaded, 18, Part Number 9080L-18U; 1.4mm x 18 Threaded Nitinol Guide Wire, Part Number 9080-N-18T; 1.4mm x 18 Non-Threaded Nitinol Guide Wire, Part Number 9080-N-18U The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone

    FDA Enforcement
    Class II ·Terminated·Amendia, Inc·December 28, 2016