BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    CCI CORNEAL SCARIFIER

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

    Natural Profile Healing Abutment 4.0mm x 1.0mm, NP, Ti

    FDA UDI
    STERNGOLD DENTAL LLC·00841549111693·Devices are used in dental implant applications...

    IVAC VENTED/UNVENTED TUBING

    FDA Adverse Event
    Malfunction ·ALARIS MEDICAL SYSTEMS, INC.·Product code FPA·July 15, 1999

    BD PLASTIPAK LUER-LOK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 17, 2020

    SONOACE 88 PORTABLE ULTRASOUND SCANNER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ARTHROSCOPIC ELECTROSURGICAL PROBE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TI PROXIMAL EXTENSION SIZE 10/220MM RADIUS

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code MDI·December 24, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-REDWOOD CITY·Product code MGB·November 22, 2010

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2014

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·December 4, 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