BEUDAMED
    8 results · 23ms · 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 ×

    Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)

    FDA 510(k)
    FDA Class 2 ·Neurology

    ChoiceSpine Blackhawk Ti Cervical Spacer System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EmbryoSlide+ ic8 dish

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

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·November 11, 2014

    CATH-LAB SHEATH INTRO SE T:

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DYB·August 24, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 23, 2013

    BD VEO INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·October 6, 2020

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025