BEUDAMED
    11 results · 31ms · Sources: EU EUDAMED, US FDA

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    EndoTool IV Cloud 1.0

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ZEUS-P

    FDA UDI
    SPINAL ELEMENTS·00840916123093·Zeus-P Implant 10 x 9 x 26mm

    Inspire Lumbar Interbody Fusion System

    FDA UDI
    CURITEVA, INC.·B648C33426091001·Porous PEEK PLIF Spacer, 26 x 9 x 10mm, 0 deg

    Scorpio

    FDA UDI
    Howmedica Osteonics Corp.·07613327030051·Tibial Bearing Insert - CR

    ZEUS-P

    FDA UDI
    SPINAL ELEMENTS·00840916153601·Zeus PLIF, Curved Cage 26mm x 09mm x 10mm

    POWDERED FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Elecsys Syphilis

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BUTTRESS/COMPRESSION NUT FOR 357.369

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HST·November 19, 2014

    SEE H-10

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code HQL·September 23, 2011

    DESARA

    FDA Adverse Event
    Injury ·CALDERA MEDICAL, INC.·Product code FTL·July 23, 2013

    Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2-TORNADO-01 G47417 MWCE-18S-3/2-TORNADO-081800 G13102 MWCE-18S-3/2-TORNADO G08261 MWCE-18S-4/2-TORNADO-081800 G13103 MWCE-18S-4/2-TORNADO G08357 MWCE-18S-5/2-TORNADO-01 G47418 MWCE-18S-6/2-TORNADO-01 G47419 MWCE-18S-6/2-TORNADO-081800 G13105 MWCE-18S-5/2-TORNADO-081800 G13104 MWCE-18S-2/4-TORNADO-LEF G09945 MWCE-18S-2/5-TORNADO-LEF-081800 G13108 MWCE-18S-4/3-TORNADO G12924 MWCE-18S-2/3-TORNADO-LEF G09944 MWCE-18S-2/3-TORNADO-LEF-081800 G13106 MWCE-18S-2/4-TORNADO-LEF-081800 G13107

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·June 15, 2022