BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    HENNING MENISCAL SUTURE KIT

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    Arctic Sun Stat Temperature Management System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IVY COMMANDEER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ABX MINOTROL 16

    FDA Adverse Event
    Other ·HORIBA MEDICAL·Product code GKZ·June 6, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 2, 2014

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code ILS·November 23, 2012

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·September 13, 2010

    PKG, 5MM INSERT, PADDLE BABCOCK, 33CM, P/N 0250080700 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