BEUDAMED
    9 results · 18ms · 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.

    DIASTAT ENA SINGLE WELL SCREEN KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    CCI CORNEAL SCARIFIER

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

    STONE BASKET

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

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 21, 2024

    COULTER® ACT DIFF ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·February 5, 2013

    ASKU

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code DTB·January 3, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 18, 2014

    KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology

    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