BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    KLOCKNER DENTAL IMPLANT, MODEL S3M

    FDA 510(k)
    FDA Class 2 ·Dental

    HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOWMEDICA OSTEONICS SHOULDER SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLORADO 2 SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·January 22, 2009

    COLORADO 2 SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 23, 2012

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 13, 2011

    PLACEHIT WALLSTENT BILIARY ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC, IRELAND, LTD.·Product code FGE·May 22, 2008

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 24, 2016

    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