BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471150751·K-WIRE - SINGLE TROCAR 1.25mm DIA x 200mm

    SMART SCALE X-RAY PLATFORM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MINIMED MODEL 404-S EXTERNAL INFUSION PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SILS STITCH SUTURING DEVICE

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY US·Product code KOG·May 22, 2014

    SHILEY

    FDA Adverse Event
    Death ·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code JOH·February 11, 2013

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·January 19, 2011

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013