BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    TRACE GAMMA GT-SS REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DISPOSABLE RETRACTABLE NEEDLE SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    QUALITONE ITE GENESIS

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    LEXINGTON MEM W COLUMBIA SC 2

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·October 30, 2013

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·May 31, 2018

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·May 18, 2018

    FLANGE FIXTURE AND ABUTMENT

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·January 14, 2013

    REFURBED COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 3, 2010

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD.·Product code MCM·July 4, 2014

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·March 8, 2022

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·December 10, 2019

    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