BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    HAND/FOOT 624-208

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

    XW-100 Automated Hematology Analyzer for CLIA Waived Use

    FDA 510(k)
    FDA Class 2 ·Hematology

    DUO TEMP

    FDA 510(k)
    FDA Class 2 ·Dental

    COOK ECHOTIP AMNIOCENTESIS NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code HIO·December 19, 2017

    DEPTH GAUGE FOR 2.7MM & SMALL SCREWS

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTJ·January 5, 2021

    LIFEVEST WCD 4000 SYS

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 23, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·October 8, 2010

    CORTEX SCREW

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·December 7, 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