BEUDAMED
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    TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046

    FDA 510(k)
    FDA Class 2 ·Immunology

    Mariner

    FDA UDI
    Seaspine Orthopedics Corporation·10889981129293·Tissue Retractor, Long

    TCP

    FDA UDI
    WRIGHT MEDICAL TECHNOLOGY, INC.·00840420117854·

    S57D DIGITAL OPERATING ROOM CAMERA

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LUCAS 2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MASUNAGA since 1905

    FDA UDI
    MASUNAGA OPTICAL MFG.CO.,LTD.·04582644465200·

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·May 6, 2014

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·January 7, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 16, 2010

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·April 15, 2024

    HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code FKX·October 21, 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