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

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    Mammotome revolve Dual Vacuum Assist Biopsy System

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

    AGC KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304243019·

    DP240 240 HOUR DOPPLER PROBE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    DA+ T SERIES

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code DXY·June 8, 2013

    THE EMAX 2 PLUS SYSTEM

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 8, 2014

    TERUMO TCM II COOLING AND HEATING SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DWC·June 17, 2011

    Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

    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

    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