BEUDAMED
    23 results · 40ms · Sources: EU EUDAMED, US FDA

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    OLYMPUS PREALBUMIN CALIBRATOR, ODR3029

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFICATION TO ISOLA SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ATAC PAK ALP REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·April 19, 2023

    Cook

    FDA UDI
    COOK INCORPORATED·00827002028050·Pressure Monitoring Set

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·September 27, 2017

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·September 27, 2017

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·September 27, 2017

    TSRH

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·May 12, 2017

    GII ARTICULAR INSERTER/EXTRACT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBH·February 9, 2018

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 2, 2018

    EON MINI

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 29, 2013

    MYOSURE TISSUE REMOVAL DEVICE

    FDA Adverse Event
    Injury ·HOLOGIC, INC.·Product code HIH·March 23, 2011

    CONQUEST PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·April 21, 2008

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·June 21, 2011

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·June 21, 2011

    TSRH

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·March 29, 2016

    TSRH

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·March 29, 2016

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·March 25, 2011

    Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·March 2, 2016