BEUDAMED
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    CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)

    FDA 510(k)
    FDA Class 1 ·Hematology

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971840·

    Finessis Intense Polyisoprene Surgical Glove

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

    CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BECKER EDMS, BLUE CAP, STOPCOCK BELOW DRIP CHAMBER

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROSURGERY·Product code JXG·June 13, 2014

    GLUCOSE MONITORING SYS/KIT

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 18, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 13, 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