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

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    EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    NEEDLE HOLDER

    FDA UDI
    KLS-Martin L.P.·00888118118790·CASTROVIEJO, W/LOCK, CURVED, TITANIUM

    CORTICAL BONE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THORA-KLEX CHEST DRAINAGE UNIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    REVO MRI SURESCAN

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

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·January 10, 2011

    11CM ANGLE ATTACHMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·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