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

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    WHEELCHAIR LIFT (WHEELCHAIR ELEVATOR)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EDENTA

    FDA UDI
    EDENTA ETABLISSEMENT·E312K90044710001·Dowel Pin 17 mm

    Intervertebral Body Fusion Device

    FDA UDI
    PRECISION SPINE, INC.·00840019925068·Install Guide ALIF Stabilizer 17mm

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/11 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 26, 2020

    CONVERTORS EQUIPMENT DRAPES

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

    AXXENT FLEXISHIELD MINI

    FDA 510(k)
    FDA Class 2 ·Radiology

    AXXENT FLEXISHIELD MINI (K090417)

    FDA Adverse Event
    Injury ·XOFT, INC.·Product code IXI·January 7, 2011

    54 CM BIPOLAR LEAD

    FDA Adverse Event
    Malfunction ·GREATBATCH MEDICAL·Product code DTB·May 6, 2014

    ULTRAFLEX¿ TRACHEOBRONCHIAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code JCT·January 7, 2013

    VISISTAT SKIN STAPLER

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code GDT·October 27, 2010

    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