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

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    NobelDesign Software

    FDA 510(k)
    FDA Class 2 ·Dental

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528128114·3.0 X 36mm Cannulated Headless Screw, T10

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707014904·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 36

    U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS

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

    ALLOFUSE PLUS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018

    CARELINK

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DXY·June 8, 2013

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DTQ·June 17, 2011

    RESURFACING

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·October 8, 2014

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018

    HNM LATERAL ANCHOR

    FDA Adverse Event
    Injury ·HNM STAINLESS, LLC DBA HNM MEDICAL·Product code HWC·April 16, 2018

    DILATOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DRE·August 13, 2021

    DILATOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DRE·July 27, 2022

    COONS DILATOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DRE·July 28, 2022

    ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 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