BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    Surgical Gut Suture

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Sonic

    FDA UDI
    Sonic Innovations, Inc.·05711583025117·BL100 NR, PS MBE BLISS 100

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776304669·Grooved Director 6" tongue tie with probe

    SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DOUBLE MOBILITY HC LINER 28/DMD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·September 8, 2016

    T7 DRIVER CANN AO

    FDA Adverse Event
    Malfunction ·BIOMET ORTHOPEDICS·Product code LXH·July 14, 2016

    PELVICOL ACELLULAR COLLAGEN MATRIX

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·January 30, 2013

    PORTUGESE PLUM A+ SW

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·September 26, 2014

    CONTOUR TEST STRIPS

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·June 21, 2011

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·April 14, 2015

    Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD

    FDA Enforcement
    Class II ·Ongoing·Ventana Medical Systems, Inc.·August 28, 2024

    ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·October 17, 2018