BEUDAMED
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    SPECTACLE FRAMES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SeaSpine Spacer System - Pacifica

    FDA UDI
    Seaspine Orthopedics Corporation·10889981088071·Threaded Removal Tool

    LAURIMED POLYPVAC MICRODEBRIDER

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    TELECARE D.R. SERVER SOFTWARE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FIRST PICC

    FDA Adverse Event
    Malfunction ·ARGON MEDICAL DEVICES, INC.·Product code FOZ·January 22, 2013

    CARDIOPULMONARY BYPASS HEART-LUNG MACHINE CONSOLE

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·December 13, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 14, 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