BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    Reline System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Sklar

    FDA UDI
    SKLAR CORPORATION·10649111451744·KOCHERNIPPON HEMO FCP STR 7 INCHES

    DUOFERTILITY

    FDA 510(k)
    FDA Unclassified ·Unknown

    ORION ANTERIOR CERVICAL PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/12 MM LEFT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 24, 2016

    VITEK MASS SPECTROMETER

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, SA·Product code PEX·October 12, 2017

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X55 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·October 6, 2014

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code MMI·June 3, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024