BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    AEGIS ANTERIOR LUMBAR PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704284638·SCALP CONTOUR RETRACTOR 5 1/2" 3X4 BLUNT

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·14026704920942·

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776098285·Contour Scalp Retractor

    CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE

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

    OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    FDA Adverse Event
    Malfunction ·BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND·Product code FMI·January 26, 2024

    INCEPTA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 8, 2011

    PERCUTANEOUS THROMBOLYTIC D

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code DXE·May 22, 2008

    FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·April 24, 2019

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

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

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016