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

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    FRASER HARLAKE EMERG. CARE SUCTION SYS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EVOTECH™

    FDA UDI
    ADVANCED STERILIZATION PRODUCTS SERVICES INC.·10705037049509·Connector Tube, Yellow

    E-LINE

    FDA UDI
    Richard Wolf GmbH·04055207010129·CUTTING ELECTRODE MONO 16FR 0° for resectoscop...

    FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5

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

    SERIES 4000 STRESS & EXERCISE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON INC·Product code FTL·November 21, 2012

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 12, 2015

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code LXH·September 17, 2010

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    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