BEUDAMED
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    CARDIOPLEGIC SETS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FacetLINK MI

    FDA UDI
    LINKSPINE, INC.·00817329024576·Jamshidi Needle

    ACUMED

    FDA UDI
    Acumed LLC·10806378100130·ARH Slide-Loc™ Locking Guide Base +1 mm

    FM-02 BONE GRAFT SUBSTITUTE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS

    FDA 510(k)
    FDA Class 2 ·Dental

    TENDRIL STS

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·May 9, 2014

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCLUAR SYSTEM CORP·Product code DTQ·October 19, 2012

    WAVEON CRX

    FDA Adverse Event
    Injury ·SONOMA ORTHOPEDIC PRODUCTS, INC.·Product code HSB·August 6, 2010

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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