BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    Freedom Spinal Cord Stimulator (SCS) System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ceramco® II Silver™

    FDA UDI
    Dentsply International Inc.·D0011827200·B Masking, Red-Yellow

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100974·DESMARRES LID RETRACTOR #2

    MCKESSON HORIZON CARDIOLOGY

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    6000CMS

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·June 11, 2013

    THE EMAX 2 PLUS SYSTEM

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

    GE OEC 7600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC·Product code JAA·September 25, 2008

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMI·July 30, 2021

    BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·October 25, 2023

    BD PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·February 23, 2021

    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