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

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    MEDI-VAC FLEXI-CLEAR SUCTION HANDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MECHANICAL OXYGEN REGULATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    A2J TELEMETER

    FDA 510(k)
    FDA Class 1 ·Radiology

    METRX

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·February 15, 2013

    ADVANTA

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·December 21, 2010

    ITOTAL G2

    FDA Adverse Event
    Injury ·CONFORMIS·Product code JWH·July 11, 2014

    TSH, THYROTROPIN

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·April 9, 2014

    TSH, THYROTROPIN

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·March 24, 2014

    FT4, FREE THYROXINE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CEC·February 20, 2014

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    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