BEUDAMED
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    DePuy ATTUNE™ Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Crosperio RX PTA Balloon Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·June 4, 2019

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 9, 2011

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·September 4, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 29, 2013

    SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·March 1, 2024

    SHIDEN

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·July 10, 2020

    DIVA

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·July 7, 2020

    DIVA

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·July 7, 2020

    Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).

    FDA Enforcement
    Class II ·Terminated·Diagnostica Stago, Inc.·December 26, 2018

    SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·April 18, 2022

    SHIDEN

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·September 2, 2021

    SHIDEN

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·January 6, 2022

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014