BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    Tinnitogram Signal Generator

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JUMP START, MODEL 970300

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    REAMER 4.5/6.5 L450 F/HIP SCR F/EXPERT

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTO·June 30, 2020

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 3, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 24, 2011

    URETEX TO2 URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·May 22, 2013

    VAPR VUE GENERATOR

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code GEI·January 29, 2019

    1.25MM THREADED GUIDE WIRE

    FDA Adverse Event
    Malfunction ·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code LRN·February 6, 2018

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015