BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    SPYROCOLLOID WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    2710-000 OSCILLATING SAW, GENERAL ASSEMBLY

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SENSIA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·February 11, 2013

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·January 10, 2011

    AL-III W/FOOT CONTROL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GEY·December 13, 2013

    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