BEUDAMED
    12 results · 25ms · Sources: EU EUDAMED, US FDA

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    AOS Calcaneal Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    XYCOR SPINAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 14, 2025

    2182466-2007-00003

    FDA Adverse Event
    Death ·Product code BZO·April 13, 2007

    2182466-2003-00001

    FDA Adverse Event
    Death ·Product code DSA·January 10, 2003

    2182466-2007-00001

    FDA Adverse Event
    Injury ·Product code BZO·March 20, 2007

    2182466-1999-00001

    FDA Adverse Event
    Death ·Product code DQA·July 23, 1999

    11CM ANGLE ATTACHMENT, BLACK MAX

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 17, 2014

    9400

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 14, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 18, 2011

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators 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; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

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