BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    SHILEY ARTERIAL FILTER W/40 MICRON SCREE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cochlear

    FDA UDI
    COCHLEAR LIMITED·09321502042925·CP1000 Processing Unit, Black, Platinum Detail

    AUDIT MICROLQ SPINAL FLUID CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TEETHMATE F-1

    FDA 510(k)
    FDA Class 2 ·Dental

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 25, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code NVY·October 31, 2012

    CAROTID WALLSTENT MONORAIL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIM·August 24, 2010

    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