BEUDAMED
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    DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690197669·AK3 PS-C Insert Trial Size 1, 14mm

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471150720·K-WIRE - SINGLE TROCAR 1.1mm DIA x 100mm

    ANATECH X-RAY GENERATOR

    FDA 510(k)
    FDA Class 1 ·Radiology

    2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA)

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNKNOWN DEPUY HIP LINER

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JDI·March 8, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    MEDTRONIC MINIMED·Product code OYC·August 8, 2014

    CE INTERMATE SV 100, 48 PACK,50125

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·February 16, 2011

    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