BEUDAMED
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    DATA TRAC ANESTHESIOLOGY RECORDER

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SyncVision System

    FDA 510(k)
    FDA Class 2 ·Radiology

    ALL PURPOSE CUFF, MODEL 222APC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCU-CHEK ® AVIVA COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·June 5, 2014

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 4, 2010

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·November 29, 2012

    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