BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    SAXON WET LUBE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MULTI ADJUSTABLE FACE MASK

    FDA 510(k)
    FDA Class 2 ·Dental

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 30, 2024

    ENDURANT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·June 27, 2014

    ACCU-CHEK ® SMARTVIEW TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·January 7, 2013

    NEXGEN MIS TRABECULAR METAL TIBIAL TRAY

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code JWH·October 26, 2010

    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