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

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    MODIFICATION TO GFX NERVE ABLATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    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

    SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FOCUS

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    FINESSE ULTRA 14

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCUALR, INC·Product code KNW·April 16, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP.·Product code MKJ·April 12, 2011

    UNK ZIMMER KNEE

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

    TRIATHLON #4 PS INSERT 11MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·August 23, 2013

    GORE® TRI-LOBE BALLOON CATHETER

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DQY·February 24, 2021

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015