BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    DERMAL GLOVES

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

    TIDISHEILD

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

    EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT

    FDA 510(k)
    FDA Class 2 ·Dental

    ADVIA CENTAUR TOTAL HCG (THCG) AND PROGESTERONE

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JHI·March 5, 2010

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·January 29, 2013

    C-TAPER COCR LFIT HEAD 36MM/-5

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·December 15, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 14, 2014

    Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410

    FDA Enforcement
    Class I ·Terminated·BioMedical Equipment Service Co (BMES)·August 18, 2021

    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