BEUDAMED
    17 results · 34ms · Sources: EU EUDAMED, US FDA

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    DRITRAINER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89300051·Mand. 1. Molar band W-Fit right 05

    CHIMAERA Hip Fracture System

    FDA UDI
    ORTHOFIX SRL·18054242514848·CHIMAERA HFS END CAP L5MM STERILE

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89300050051·Mand. 1. Molar band W-Fit right 05

    Breeze Nasal Airway

    FDA UDI
    Summit Medical, Inc.·00385640000147·

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89300050101·Mand. 1. Molar band W-Fit right 05

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89300050501·Mand. 1. Molar band W-Fit right 05

    Guided Surgery

    FDA UDI
    BICON, LLC·00813110026149·3.0mm Guided Surgery Rings

    Grasping forceps

    FDA UDI
    SOPRO-COMEG GmbH·04059082022772·

    VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Pantheris LV Atherectomy Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SAVINA 300

    FDA Adverse Event
    Malfunction ·DRAGER MEDICAL GMBH·Product code CBK·June 9, 2015

    STERIS SYSTEM 1E

    FDA Adverse Event
    STERIS CORPORATION - HOPKINS·Product code MED·January 25, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·December 2, 2010

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 11, 2014

    BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code LXG·October 10, 2019

    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