BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress

    FDA 510(k)
    FDA Class 2 ·Dental

    PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EXSALT SD7 WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    SPRINT QUATTRO SECURE MRI SURESCAN

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

    TERUMO ADVANCED PERFUSION SYSTEM 1

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

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO, S.A. DE C.V.·Product code NIQ·September 8, 2008

    GMK-REVISION REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 23, 2018

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    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