BEUDAMED
    13 results · 27ms · Sources: EU EUDAMED, US FDA

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    SUTURE REMOVAL PAK

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    VITROS

    FDA UDI
    ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750006946·VITROS Chemistry Products mALB Performance Veri...

    Symmetry Rhoton®

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482031742·Rhoton® Needle Holder, Bayonet, Straight

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209136285·

    LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 8, 2014

    SILSOFT SUPER PLUS (ELASTOFILCON A) LENS

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code LPM·October 12, 2012

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 27, 2007

    ARCHITECT C8000

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·June 18, 2021

    Metal Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02, 03-600-03, 03-6000-04, OrthoPro LLC, Salt Lake City, UT Hemi is designed to supplement first metatarsal Phalangeal joint arthroplasty.

    FDA Recall
    Terminated ·OrthoPro LLC·Product code KWD·May 29, 2008

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 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