BEUDAMED
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    AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Joline Kyphoplasty System Allevo

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRIMUSRS

    FDA Adverse Event
    Malfunction ·BTE TECHNOLOGIES, INC.·Product code BXB·February 26, 2013

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code NVZ·August 8, 2014

    CAPSURE SP NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

    DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG),impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM).

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·December 19, 2012

    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