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

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    FDA 510(k)

    SureLead Cable System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 9, 2014

    EXTERNAL PULSE GENERATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·October 31, 2012

    CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·August 11, 2010

    B125P Patient Monitor (with E-module slot option), REF 6160000-002

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

    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