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

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    ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    COSMED PONY FX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CK-B RIA KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MESH

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 30, 2013

    TM PRIMARY HIP FEMORAL STEM PRESS-FIT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWY·December 21, 2010

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·July 17, 2014

    PKG, 5MM INSERT, BOWEL GRASPER FORCEPS, 45CM, P/N 0250080587 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014