BEUDAMED
    11 results · 44ms · Sources: EU EUDAMED, US FDA

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    GRYPHON® Anchors with DYNACORD™ Suture

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Origin Broach

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215039783·

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161111818090·Kratos Broach S-Type, Size 18

    311NNM NARROWAND UV PHTOTHERAPY LIGHT LAMP

    FDA Adverse Event
    Injury ·XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD.·Product code FTC·December 22, 2022

    FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS

    FDA 510(k)
    FDA Class 2 ·Dental

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·August 20, 2020

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·June 6, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    GE OEC 6600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 19, 2008

    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