BEUDAMED
    32 results · 26ms · Sources: EU EUDAMED, US FDA

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    AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ASSUFIL

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

    DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 8, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 8, 2025

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 29, 2013

    SM204 M-SERIES W/BIG WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·April 13, 2011

    VERSYS HIP SYSTEM FEMORAL STEM BEADED FULLCOAT COLLARED

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code LPH·July 25, 2008

    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

    UNIVERSA SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·September 25, 2018

    UNIVERSA SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·September 26, 2018

    PVA FOAM EMBOLIZATION PARTICLES

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRD·March 26, 2018

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZN·April 7, 2017

    UNIVERSA SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·July 8, 2019

    UNIVERSA SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·November 14, 2017

    UNIVERSA SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·November 19, 2018

    UNIVERSA SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·July 19, 2018

    UNIVERSA SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·August 1, 2018

    UNIVERSA SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·August 22, 2018

    UNIVERSA SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·February 21, 2018