BEUDAMED
    15 results · 26ms · Sources: EU EUDAMED, US FDA

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    Mammo Workstation

    FDA 510(k)
    FDA Class 2 ·Radiology

    CERVICAL PLATE VARIABLE SELF-DRILLING SCREW DIAM. 4X16MM (2X)

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWQ·November 10, 2016

    CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X14MM (2X)

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWQ·September 13, 2018

    SECURIS SPINAL FIXATION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCUHEART ELECTRODE BELT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MECTA C VARIABLE SELF-DRILLING SCREW DIAM. 4X18MM (2X)

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWQ·June 24, 2022

    CERVICAL PLATE VARIABLE SELF-TAPPING SCREW DIAM. 4X14MM (2X)

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWQ·June 8, 2018

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 3, 2013

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·June 29, 2011

    MAESTRO MEDIUM FIXED DURAGUARD

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·October 6, 2014

    SENSITHERM PROBE

    FDA Adverse Event
    Injury ·FIAB S.P.A.·Product code FLL·July 10, 2023

    STARDRIVE SCREWDRIVER T25/SELF-RETAINING

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HXX·August 5, 2015

    CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X18MM (2X)

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWQ·September 15, 2021

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 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