BEUDAMED
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    VICHY SHOWER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Modulus Expandable

    FDA UDI
    Nuvasive, Inc.·00195377056047·MOD-EX PL Trial, 9x9mm

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M930798090910·Stainless Frazier Suction 9FR 8" from bend

    ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000

    FDA 510(k)
    FDA Class 2 ·Immunology

    REVEL Spacers

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOFTCLIX ® PLUS LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·February 27, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·February 7, 2011

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·August 5, 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