BEUDAMED
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    LM-850 AUTOMATIC LENSMETER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Signature

    FDA UDI
    SILEX MEDICAL, LLC·B3315861064·Locking Soft Curved Dissecting Forceps

    Signature

    FDA UDI
    SILEX MEDICAL, LLC·B331586106445·Locking Long Soft Curved Dissecting Forceps

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011861064180·Mini-Assortment Standard Bands, Tooth 44/34, Ro...

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011861064220·Mini-Assortment Standard Bands, Tooth 44/34, Ro...

    Penumbra System ACE 68 Reperfusion Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503

    FDA 510(k)
    FDA Class 2 ·Hematology

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 10, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·October 7, 2010

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 3, 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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012