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

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    Mammotome AutoCore™ Single Insertion Core Biopsy System

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

    ROCHE DIAGNOSTICS ELECSYS AFP CALSET II

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MiniStim MS-IVB Peripheral Nerve Stimulator

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·March 1, 2023

    MAGELLAN SAFE BC HLDR 1.25X22G

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code JKA·November 21, 2008

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011

    HUDSON SPIRAL-FLEX ENDOTRACHEAL TUBE, 8.0MM

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTR·July 18, 2013

    PKG, 5MM, 45CM, INSERT, FENESTRATED FORCEPS, P/N 0250080732 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