BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    ESB 2400 SEI

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SeaSpine Spacer System - Pacifica

    FDA UDI
    Seaspine Orthopedics Corporation·10889981088194·Box Cutter, 9mm x 18mm

    TONO-PEN TONOMETER TIP COVER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BAUSCH + LUMB, VIS100 INJECTOR SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    PUMP MMT-722LNAB PRDGM INS BL EN ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·December 14, 2010

    ONCOSMART PROGUIDE NEEDLE

    FDA Adverse Event
    Other ·NUCLETRON·Product code JAQ·January 25, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 14, 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