BEUDAMED
    20 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 ×

    Crosperio RX PTA Balloon Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·June 4, 2019

    SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·March 1, 2024

    SHIDEN

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·July 10, 2020

    DIVA

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·July 7, 2020

    DIVA

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·July 7, 2020

    SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·April 18, 2022

    SHIDEN

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·September 2, 2021

    SHIDEN

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·January 6, 2022

    SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510

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

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·June 8, 2013

    LIFEPAK CR PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·June 28, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 10, 2008

    14 SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·September 26, 2024

    14 SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·February 4, 2025

    14 SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·February 13, 2025

    14 SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·June 20, 2025

    VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000

    FDA Enforcement
    Class I ·Ongoing·Ventec Life Systems, Inc.·May 13, 2026

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023