BEUDAMED
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    UNIVERSAL DRIVE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091981269·anteriors; shade C1; mould US2

    Symmetry Surgical®

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482087442·Symmetry® Forceps, Claw, Ratcheting Handle, 10 mm

    iCertainty

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AVIE A1C TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, INC.·Product code GDO·March 20, 1998

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 27, 2013

    FREESTYLE LITE TEST STRIP 100

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

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

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

    L.C. 5000/CE 2-CHANNEL PUMP (50/CASE)

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·August 22, 2013

    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