BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    Nephros S100

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

    NEODENT GRAFT SCREW

    FDA 510(k)
    FDA Class 2 ·Dental

    SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    AXIOS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024

    AXIOS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 19, 2025

    AXIOS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 17, 2024

    AXIOS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 20, 2025

    AXIOS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024

    CAPSUREFIX MRI

    FDA Adverse Event
    Malfunction ·MPRI·Product code NVN·June 8, 2013

    ASR UNI FEMORAL IMPL SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 20, 2011

    DBS

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROLOGICAL·Product code MHY·September 8, 2008

    AXIOS?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024

    AXIOS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 27, 2024

    Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 14, 2016

    GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·June 28, 2017

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

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

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012