BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    21 HEMATOLOGY REAGENTS

    FDA 510(k)
    FDA Class 2 ·Hematology

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690128991·Revision Tibia Augment Peg Bolt Size 4mm

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209118151·

    COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Hansen Medical Magellan Robotic Catheter eKit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·November 30, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 23, 2014

    MICROAIRE

    FDA Adverse Event
    Injury ·MICROAIRE SURGICAL INSTRUMENTS·Product code HWE·September 29, 2010

    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