BEUDAMED
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    MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL

    FDA 510(k)
    FDA Class 2 ·Neurology

    BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN

    FDA 510(k)
    FDA Class 2 ·Dental

    TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AFFINITY VDR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·February 28, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAB

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·January 20, 2011

    SUPER SUCKER SHORT (BX/20)

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code KDC·December 18, 2013

    Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·April 23, 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