BEUDAMED
    12 results · 25ms · Sources: EU EUDAMED, US FDA

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    FLEXIBLE INTRACARDIAC SUCTION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SURETAC

    FDA UDI
    Smith & Nephew, Inc.·03596010444592·MTO SURETAC 8MM IXC SHORT CANNULA

    MOR® Alignment Guide

    FDA UDI
    STERNGOLD DENTAL LLC·00841549118418·Used to provide visual alignment of implant or ...

    Eclipse®

    FDA UDI
    Dentsply International Inc.·D0019050080·Light Pink

    Duo Lumbar Interbody Fusion Device

    FDA UDI
    SPINEOLOGY INC.·M7402905008·Duo, Non-Lordotic, 50 x 8mm

    HEXASCAN HANDPIECE

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

    DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET

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

    PRIMEWIRE PRESTIGE PLUS

    FDA Adverse Event
    Malfunction ·VOLCANO S.R.L.·Product code DQX·May 27, 2014

    BIPOLAR POLYURETHANE LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 9, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-REDWOOD CITY·Product code MGB·November 22, 2010

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024