BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    C0-AXIAL INTRODUCER NEEDLE

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

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091981721·anteriors; shade D4; mould UM8

    TRICOS A RESORBABLE SUBSTITUTE

    FDA 510(k)
    FDA Class 2 ·Dental

    Ceracell Ortho Foam

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·February 27, 2013

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 8, 2011

    SENSOR ENLITE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·August 5, 2014

    ARCHITECT C16000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·May 10, 2019

    GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016