BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    SMART Bun-Yo-Matic X-Ray

    FDA 510(k)
    FDA Class 2 ·Radiology

    Best Medical International

    FDA UDI
    BEST MEDICAL INTERNATIONAL, INC.·00841365120695·

    STERISAFE HP TABLE-TOP STEAM STERILIZER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VAXCEL PLUS CHRONIC DIALYSIS CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    ELLIPSE DR, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·November 10, 2014

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·September 9, 2011

    ILS 29MM, CURVED

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 22, 2013

    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020

    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