BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    HARDYDISK OXACILLIN, 1MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    INCUBATOR 8000 SC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    POWER EXAMINATION TABLE MODEL # 411

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

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 13, 2013

    ATTAIN OTW

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 16, 2011

    UNKNOWN DEPUY PATELLAR COMPONENT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JWH·August 8, 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