BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    FUTURA JUNIOR 300/310

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GE SIGNA EXCITE MR SURGICAL OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DCCU-CHEK FLEXLINK

    FDA Adverse Event
    Malfunction ·ROCHE HEALTH SOLUTIONS, INC.·Product code FPA·January 21, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·January 1, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 18, 2014

    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

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015