Device Recall Apex

  • Modelo / Serial
    All Lots.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Apex Oxygenator, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy. || Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

39 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Product Code KC-2206L, Lot # 26519
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Distribution and to the country Spain.
  • Descripción del producto
    Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L || The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed.
  • Manufacturer
  • Modelo / Serial
    Software versions v3.8 and earlier.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution --- including states of AL, AR, AZ, CA, CO, Washington DC, FL, IL, IN, ME, MI, MN, MO, NC, NE, NJ, NY, OK, PA, SC, TX, VA, WA, WI, WV.
  • Descripción del producto
    ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patient worn acquisition transceivers, the patient worn data acquisition transceivers, the transceiver access points with antenna, the network infrastructure, A computer platform running the ApexPro Telemetry Application and a computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application). GE Medical Systems information Technologies, 8200 West Tower Avenue, Milwaukee, WI 53223.
  • Manufacturer
  • Modelo / Serial
    All Lots.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Apex SMART PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy. || Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours.
  • Manufacturer
  • Modelo / Serial
    All Lots.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Apex Phisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy. || Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours.
  • Manufacturer
  • Modelo / Serial
    All Lots.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Apex HP Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy. || Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours.
  • Manufacturer
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