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

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    ACROMED TIMX PLATE BASED LOW BACK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091981274·anteriors; shade C2; mould CS2

    Symmetry

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482087510·Symmetry® Forceps, Spoon, Auto Closure Handle w...

    GAMMA MED II

    FDA 510(k)
    FDA Class 2 ·Radiology

    SURESKIN SILVER BANDAGES

    FDA 510(k)
    FDA Unclassified ·Unknown

    OPTI-FREE PLUS

    FDA Adverse Event
    Injury ·ALCON LABORATORIES, INC.·Product code LPN·December 12, 2017

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·February 27, 2013

    FREESTYLE TEST STRIPS 100'S

    FDA Adverse Event
    Malfunction ·ABBOTT·Product code NBW·February 2, 2011

    OBTAPE TRANSOBTURATOR SLING

    FDA Adverse Event
    Injury ·MENTOR WORLDWIDE LLC·Product code OTN·July 24, 2014

    The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile, Single use only --- Manufactured for: Circulatory Technology Inc., 21 Singworth Street, Oyster Bay, 11771 (516) 624-2424 --- 510 (k) 981284.

    FDA Recall
    Terminated ·Circulatory Technology Inc·Product code DTN·June 3, 2009

    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