BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    PHARMACIA DELTEC BAG SPIKE SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Cybird LED Curing Light

    FDA 510(k)
    FDA Class 2 ·Dental

    BERKELEY FORK

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    NI

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·May 14, 2021

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 5, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·October 19, 2010

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 14, 2012

    COBE SPECTRA BLOOD COLLECTION

    FDA Adverse Event
    TERUMO BCT·Product code GKT·April 24, 2013

    UNKNOWN OPTEASE VENA CAVA FILTER

    FDA Adverse Event
    Injury ·CORDIS CORPORATION·Product code DTK·June 29, 2015

    UNKNOWN OPTEASE VENA CAVA FILTER

    FDA Adverse Event
    Death ·CORDIS CORPORATION·Product code DTK·June 29, 2015

    CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    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