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

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    THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BARDEX I.C. LATEX FOLEY CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    T7 DRIVER CANN AO

    FDA Adverse Event
    Malfunction ·BIOMET ORTHOPEDICS·Product code LXH·July 14, 2016

    VERITY ADX XL

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DXY·January 13, 2014

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code OUT·May 31, 2013

    PROWLER MICROCATHETERS

    FDA Adverse Event
    Injury ·CORDIS NEUROVASCULAR, INC.·Product code KRA·June 27, 2011

    PKG, NEEDLE HOLDER, STRIAGHT, P/N 0250080340. 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