BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    BIOFORCE WIRE

    FDA 510(k)
    FDA Class 1 ·Dental

    PAQ. 210x140x200 AR2100-OEM ET MEDICAL

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763009368·

    ZAVATION

    FDA UDI
    Zavation LLC·00842166152519·WHITNEY 14mmx16mm , 9deg , 05mm

    Stryker Universal Select Sterilization Tray System

    FDA UDI
    PARAGON MEDICAL, INC.·00857387006312·2.0 MP Le-Fort Plates Inlay

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123113·K-WIRE - DOUBLE TROCAR 0.9mm DIA x 125mm

    xvision Spine System

    FDA 510(k)
    FDA Class 2 ·Neurology

    NBX - NON-BRIDGING EXTERNAL FIXATOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYMBIQ INFUSION

    FDA Adverse Event
    Malfunction ·HOSPIRA·Product code FPA·November 24, 2010

    EPIC DR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·July 8, 2014

    WATER RESISTANT EXTERNAL PADDLES

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 26, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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