BEUDAMED
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    ACA IMMUNOGLOBIN M TEST PACK

    FDA 510(k)
    FDA Class 2 ·Immunology

    A-FIT®

    FDA UDI
    Gc Orthodontics America Inc.·E53581263200001·A-FIT® 1. MOLAR UPR LFT SZ 32

    TOURNIQUET CUFF; PNEUMATIC TOURNIQUET

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    HS30 Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·May 7, 2014

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·October 31, 2012

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 17, 2010

    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