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

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    On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Bernafon

    FDA UDI
    Bernafon AG·05711584063040·SA3 CIC, V2 BE SAPHIRA 3

    MW5074159

    FDA Adverse Event
    Malfunction ·December 21, 2017

    CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELEGANCE WOMAN'S LUBRICANT

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

    CONTOUR NEXT

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·February 24, 2014

    CONTOUR NEXT

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·May 2, 2013

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·December 13, 2017

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 14, 2013

    ONMISPAN 12 DEGREE MENISCAL FASTENER

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code MBI·July 21, 2011

    COMPLETE DOUBLE MOIST

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code LPN·October 14, 2014

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024