BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    ESSE QUATTRO/ESSE UNO

    FDA 510(k)
    FDA Class 1 ·Dental

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994238740·ROD 7894060 STRAIGHT 5.5MM X 60MM PEEK

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867051683·LOW PROFILE SCREW, TI, 4.0MM X 60MM

    QUANTA FLASH H-TTG IGA

    FDA 510(k)
    FDA Class 2 ·Immunology

    RELIANCE OPHTHALMIC SLIT LAMP R-083

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PROMUS PREMIER?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 25, 2014

    CLEAR RENAL SHEATH

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - SPENCER·Product code EZN·January 3, 2013

    GORE SUTURE PASSER

    FDA Adverse Event
    Malfunction ·GORE·Product code GCJ·November 4, 2010

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020