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

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    VENOUS CANNULA TRAY

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    LUMEND FRONTRUNNER CTO CORONARY CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIOPSY POSITIONER

    FDA 510(k)
    FDA Class 2 ·Radiology

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·March 28, 2014

    SECURA DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code LWS·October 31, 2012

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·August 18, 2010

    HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·June 30, 2023

    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