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

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    QWIK-1(TM) IN-LINE IV FLUID WARMER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OSCOR MEDICAL CORP PERMANENT PACING LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    T600 TREADMILL

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    DESARA

    FDA Adverse Event
    Injury ·CALDERA MEDICAL, INC.·Product code FTL·January 8, 2013

    CLEARLNK SYSTEM Y-TYPE CATH SET/MALE LUER LOCK ADAPTER

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·December 4, 2010

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 4, 2014

    Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2

    FDA Enforcement
    Class II ·Terminated·Carefusion 2200 Inc·September 28, 2016

    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