BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS

    FDA 510(k)
    FDA Class 2 ·Dental

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·November 21, 2017

    UNKNOWN ZIMMER KNEE

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code JWH·February 12, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 29, 2014

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·January 14, 2011

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWC·March 8, 2016

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·March 11, 2016

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017