BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

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    XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and

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

    Sonic

    FDA UDI
    Sonic Innovations, Inc.·05711583025032·BL100 NR, PS DB BLISS 100

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776166786·GROOVED DIRECTOR WITH TONGUE TIE . SS

    SPIDER FLEX MONOPOLAR HOOK

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DYNACT

    FDA 510(k)
    FDA Class 2 ·Radiology

    NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD·Product code MCM·March 7, 2019

    TRANSPAC IV MONITORING KIT WITH SAFESET RESERVOIR

    FDA Adverse Event
    Malfunction ·ICU MEDICAL INC.·Product code DRS·May 3, 2017

    PELVICOL ACELLULAR COLLAGEN MATRIX

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·March 12, 2013

    PILLAR

    FDA Adverse Event
    Malfunction ·ORTHOFIX INC.·Product code LXH·May 19, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 3, 2008

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

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

    PKG, 5MM ROTATING HANDLE, W/RATCHET, INSULATED SHAFT 45CM LENGTH, P/N 0250080596 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    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