BEUDAMED
    17 results · 26ms · Sources: EU EUDAMED, US FDA

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    REPOSE BONE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    AIRVANCE BONE SCREW (REPOSE) SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code LRK·March 3, 2014

    AIRVANCE BONE SCREW (REPOSE) SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC·Product code LRK·March 29, 2013

    AIRVANCE¿ THS SYSTEM - BONE SCREW WITH SUTURE

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code LRK·November 30, 2015

    AIRVANCE¿ THS SYSTEM - TOUNGE SUSPENSION KIT

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code LRK·October 2, 2015

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091981677·anteriors; shade A1; mould UM10

    INRATIO2 PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·March 30, 2016

    INRATIO2 PT/INR TEST STRIPS

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code GJS·March 30, 2016

    SAVI APPLICATOR KIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    Kodiak Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·October 18, 2016

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 29, 2016

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

    SURGISTOOL

    FDA Adverse Event
    Malfunction ·STRYKER COP., MEDICAL DIVISION·Product code FZM·January 12, 2011

    SUPER SUCKER SHORT (BX/20)

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code KDC·December 18, 2013

    INVICTUS SPINAL FIXATION SYSTEM

    FDA Adverse Event
    Injury ·ALPHATEC SPINE, INC.·Product code NKB·April 30, 2025

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026