BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    ACE Electrosurgical Resection and Vaporization Electrodes Series

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100332·BARRAQUER INFANT WIRE SPECULUM

    SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORTHODONTIC POLYMER COMPOSITE BRACKET

    FDA 510(k)
    FDA Class 2 ·Dental

    ESON 2 NASAL MASK

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·August 14, 2019

    SPRINT QUATTRO

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

    LPS DSTL FEM COM LOPROF XSM RT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·September 5, 2008

    KINAIR

    FDA Adverse Event
    Death ·KCI USA, INC.·Product code IOQ·June 29, 2011

    FUSION ENT NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·February 2, 2021

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

    FDA Enforcement
    Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019