BEUDAMED
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    T-TUBE VENT TUBE

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

    R2GATE Lite TM

    FDA 510(k)
    FDA Class 2 ·Radiology

    AESCULAP CESPACE XP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EXT DRAINAGE SYSTEM III WITHOUT VENT CATH

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF·Product code JXG·May 21, 2014

    ALIGN TO URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code FTL·October 29, 2012

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 2, 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

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025