BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    HDL CHOLESTEROL REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    REPROCESSED FEMORAL COMPRESSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    FEMOSTOP

    FDA Adverse Event
    Malfunction ·RADI MEDICAL SYSTEMS, INC.·Product code MGB·November 21, 2003

    REALSEAL

    FDA Adverse Event
    Injury ·SYBRONENDO·Product code KIF·May 15, 2014

    ADAPTA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NVZ·October 31, 2012

    FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU

    FDA Adverse Event
    Other ·PROCTER & GAMBLE MANUFACTURING CO.·Product code KOO·August 16, 2010

    FEMOSTOP

    FDA Adverse Event
    Injury ·RADI MEDICAL SYSTEMS·Product code DXC·August 20, 2003

    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