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

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    PIN DOT ALUMINUM PAN

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377069382·RELINE C Screw, 3.5x48mm FA

    Fixion Nailing System

    FDA UDI
    CARBOFIX ORTHOPEDICS LTD·07290109331287·Cortical screw for use with humeral nails

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450582329·

    STANDARD IMAGING IVB 1000 WELL CHAMBER

    FDA 510(k)
    FDA Class 2 ·Radiology

    PEDCAT

    FDA 510(k)
    FDA Class 2 ·Radiology

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·November 12, 2010

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI PLANT - ST. PAUL·Product code LWS·July 3, 2014

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 21, 2012

    Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·August 20, 2025

    Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code OEZ·June 5, 2025