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

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    ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

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

    ProxiDiagnost N90 / Precision CRF (706110, 706400)

    FDA 510(k)
    FDA Class 2 ·Radiology

    KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)

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

    U0308 XENIUM 210G SYNTH HFDIALYZER

    FDA Adverse Event
    Injury ·NIPRO CORPORATION·Product code FKX·November 25, 2008

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·July 27, 2011

    UNKNOWN DEPUY ASR FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·July 23, 2013

    The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50.0 mm Tension Band Pin; Part Number 30-0097 70.0 mm Tension Band Pin; Part Number 30-0098 90.0 mm Tension Band Pin; Part Number 30-0099 50.0 mm Tension Band Kit; Part Number TB-1550K-S 70.0 mm Tension Band Kit; Part Number TB-1570K-S 90.0 mm Tension Band Kit; Part Number TB-1590K-S Product Usage: Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine.

    FDA Enforcement
    Class II ·Terminated·Acumed LLC·May 7, 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