BEUDAMED
    10 results · 25ms · Sources: EU EUDAMED, US FDA

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    BETTER-BLADDER (BB)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    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

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091981284·anteriors; shade C2; mould BIM6

    Symmetry

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482087633·Symmetry® Forceps, Tenaculum, Ratcheting Handle...

    VARIAX DISTAL FIBULA PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RABBIT ANTIBODY TO HUMAN T3

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·January 25, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·February 1, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·August 5, 2014

    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