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

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    VENES II

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517077094·

    GUIDEWIRE INTRODUCER SAFETY NEEDLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SHARPS TANK REUSABLE SHARPS CONTAINER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 24, 2014

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 10, 2010

    Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021