BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    BURNS CASUALTY SHEET BURN ROLL

    FDA 510(k)
    FDA Class 1 ·General Hospital

    3M™ Unitek™

    FDA UDI
    3M COMPANY·30605861028777·3M™ Unitek™ Stainless Steel Second Permanent Mo...

    EDENTA

    FDA UDI
    EDENTA ETABLISSEMENT·E312K90044510001·Dowel Pin 15 mm

    EDENTA

    FDA UDI
    EDENTA ETABLISSEMENT·E312K90044610001·Dowel Pin 12 mm

    EDENTA

    FDA UDI
    EDENTA ETABLISSEMENT·E312K90044710001·Dowel Pin 17 mm

    ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX

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

    FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 4

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 20, 2020

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 27, 2014

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code GCJ·January 7, 2013

    FREESTYLE LITE

    FDA Adverse Event
    Malfunction ·Product code NBW·November 16, 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