BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    MICROLUX DL

    FDA 510(k)
    FDA Class 1 ·Dental

    STRYKER TRAUMA PELVIC SET

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 20, 2025

    COVER, BURR HOLE

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code GXR·July 1, 2016

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·April 8, 2013

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·March 24, 2011

    PULSAR MAX DR

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008

    PKG, 5MM INSERT, TENACULUM, 33CM, P/N 0250080698 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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021