BEUDAMED
    12 results · 29ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    EVOLUTION HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Snowden-Pencer

    FDA UDI
    STERIS CORPORATION·10885403122774·Snowden-Pencer MIS DIAMOND-FLEX HOOK RETRACTOR ...

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707084822·WEB I MOL BANDS G8424-16+G2820-00 LR 5

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756659390·EENT TRAY

    ANGLED ARTICULATING TRIANGULAR RETRACTOR, 80CM

    FDA Adverse Event
    Injury ·SNOWDEN PENCER V. MUELLER, BD CAREFUSION 2200, INC.·Product code GCJ·December 28, 2021

    COAT-A-COUNT(TM) FENTANYL (TKFN1)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    INDICATENS MODEL 4X4 SP ELECTRODE STIM. PATCHES

    FDA 510(k)
    FDA Class 2 ·Neurology

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·November 10, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 22, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 10, 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

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024