BEUDAMED
    7 results · 26ms · 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.
    Filters Regulation: Us FDA ×

    ORTHOLOC ADVANTIM TIBIAL BASE COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORskin Blue

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

    THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O.

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PFC SIGMA TIB TRAY CEM SZ3

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·January 29, 2013

    CAROTID WALLSTENT MONORAIL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIM·December 20, 2010

    SITTER II

    FDA Adverse Event
    Malfunction ·J. T. POSEY CO.·Product code KMI·March 11, 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