BEUDAMED
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    CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228708041·GC Initial™ MC Dentin DA3.5, 250g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556700997·GC Initial™ MC Dentin DA3.5, 250g

    VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    The Solstice OCT System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BRACKET, SUPPORT ARM

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·June 12, 2014

    AIR OPTIX AQUA MULTIFOCAL

    FDA Adverse Event
    Injury ·PT. CIBA VISION BATAM·Product code LPM·October 11, 2010

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·December 12, 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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015