BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    3F ELECTRODE

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

    JOBST Relief

    FDA UDI
    BSN MEDICAL, INC.·04042809690019·RELIEF 15-20 MM HG KNEE HIGH OPEN TOE LARGE FUL...

    CYTOSAFE NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VIDEO PRINTER, MODEL 3200

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MPRI·Product code OJX·June 10, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·December 10, 2012

    MAYFIEL MODIFIED SKULL CLAMP

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code HBL·June 22, 2015

    VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression (PMA 970003/S050): VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. Indications outside the U.S.: Epilepsy (Non-US): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizure (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications. AspireSR (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience seizures that are associated with cardiac rhythm increases known as ictal tachycardia. Depression (Non-US): The VNS Therapy System is indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment-intolerant depressive episode.

    FDA Enforcement
    Class II ·Terminated·Cyberonics, Inc·August 23, 2017