BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    BLACK WIDOW ANTERIOR BUTTRESS PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CI TKR/UKR

    FDA 510(k)
    FDA Class 2 ·Neurology

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·April 29, 2013

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 9, 2011

    UNKNOWN ZIMMER HIP STEM

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWY·July 25, 2008

    INTRAUTERINE ACCESS BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LKF·December 10, 2020

    SELECTIVE SALPINGOGRAPHY CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LKF·November 19, 2021

    GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016

    Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNIV Z NAIL TIBIA 14MM X 42CM UNIV Z NAIL TIBIA 14MM X 44CM UNIV

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020