BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Cocoon Convective Warming System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SEASPINE MONOPOLAR PROBE SYSYEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 15, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 22, 2007

    CAPSURE SENSE

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·October 31, 2012

    BD 18 G BD NOKOR¿ 5 MICRON FILTER NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·September 14, 2023

    Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move teeth into proper alignment during orthodontic treatment. Their purpose is to create additional force for tooth movement in any of the three dimensions that is more difficult using braces alone.

    FDA Enforcement
    Class II ·Terminated·G & H Wire Company·March 10, 2021

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024