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    Adaptivo

    FDA 510(k)
    FDA Class 2 ·Radiology

    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

    TrabecuLink Tibial Cone

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575192557·TrabecuLink Tibial Cone / left half

    TrabecuLink Tibial Cone

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575192571·TrabecuLink Tibial Cone / half

    TrabecuLink Tibial Cone

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575192540·TrabecuLink Tibial Cone / right half

    TrabecuLink Tibial Cone

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575192526·TrabecuLink Tibial Cone / full

    K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CRE DITATATION BALLON

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·February 20, 2013

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - CORK·Product code KNQ·September 7, 2012

    CRE? WIREGUIDED

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·June 18, 2013

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·January 7, 2013

    RX CYTOLOGY BRUSH

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code FDX·October 8, 2014

    PROTECTA CRT-D

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 8, 2013

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DTQ·June 17, 2011

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·March 13, 2013

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·August 10, 2012

    CRE? WIREGUIDED

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·June 6, 2013

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code KNQ·December 5, 2012

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code KNQ·July 2, 2012