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

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    RN SYNOCTA TEMPORARY MESO ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    MICOR CONDUCTION CATHETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000. Product Usage: Chromophare surgical lights are medical lights for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations. The Chromophare surgical lights consist of a ceiling tube, SK Box swivel arm support, and a light head. The light head is mounted on a cardanic suspension unit and can be turned, swiveled and tilted in any direction. The spatial repositioning of the light head makes use of the 360 degree rotating swivel/horizontal arm. The 360 degree rotating spring arm is used to adjust the height. The light can be mounted in several configurations, such as a single/dual ceiling mount, a boom-integrated suspension mount, a wall mount, or a mobile roll stand.

    FDA Enforcement
    Class II ·Terminated·Stryker Communications·March 7, 2018

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 10, 2013

    SYNCHROMED EL

    FDA Adverse Event
    Injury ·RICE CREEK MANUFACTURING·Product code LKK·May 21, 2008

    CAPSURE Z NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011