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

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    CRONEX RADIATION THERAPY CASSETTE

    FDA 510(k)
    FDA Class 2 ·Radiology

    SONEX ULTRASONIC TOOTH BRUSH

    FDA 510(k)
    FDA Class 1 ·Dental

    BEAMER 1,2,4,6, AND 8

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TRELLIS 8 80X15

    FDA Adverse Event
    Injury ·COVIDIEN·Product code KRA·July 22, 2010

    ENPULSE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO·Product code NVZ·February 9, 2013

    AISYS 9R ANESTHESIA MACHINE

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code BSZ·January 7, 2011

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - CALI·Product code KDI·July 23, 2014

    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