BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    E-FAX REMOTE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SMARTSITE VIALSHIELD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ARCHITECT STAT TROPONIN-I

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MMI·December 20, 2010

    BHR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·July 14, 2014

    SM104 MSERIES W5TH WHL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·December 28, 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