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

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    WINDSOR MEDICAL, INC. 50-01-028

    FDA 510(k)
    FDA Class 2 ·General Hospital

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00810030810964·Acetabular Reamer, Full Hemisphere, Bridgeback,...

    RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SnugFit All-Suture Anchor extension

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BONE SCREWS, CROSS-PIN, DIAM.2.0X10MM, (5/PACKAGE)

    FDA Adverse Event
    Malfunction ·STRYKER LEIBINGER FREIBURG·Product code JEY·May 23, 2014

    ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Death ·COOK, INC.·Product code FGE·November 1, 2012

    PDS II (POLYDIOXANONE) SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code NEW·September 3, 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

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015