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

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    MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ECHO(TM) HIP SYSTEM INSTRUMENTATION

    FDA UDI
    Biomet Orthopedics, LLC·00880304463455·

    Echo® Hip System Instrumentation

    FDA UDI
    Biomet Orthopedics, LLC·00887868474453·

    ACCU-CHEK SMART PIX

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011

    EON MINI

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 6, 2013

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·September 9, 2008

    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