BEUDAMED
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    COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SLPSS

    FDA UDI
    SPINAL ELEMENTS·00840916118082·SLPSS Curved Rod, 85mm

    SLPSS

    FDA UDI
    SPINAL ELEMENTS·00840916118099·SLPSS Straight Rod, 85mm

    SYNGO, CT CARDIAC FUNCTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    FLOSTAR NEEDLELESS CONNECTOR, MODEL FS3000

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UNKNOWN DEPUY DURALOC CUP

    FDA Adverse Event
    Injury ·Product code JDI·November 8, 2012

    CATGUT PLAIN 3/0 (3) 75CM DS24

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL S.A.·Product code GAM·February 28, 2014

    SOLETRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·August 27, 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