BEUDAMED
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    ANA 70 DISPERSED PHASE DENTAL ALLOY -- MODIFIED

    FDA 510(k)
    FDA Class 2 ·Dental

    PRC

    FDA UDI
    PRENTKE ROMICH COMPANY·00858526006729·Via™ Pro 84 Location TouchGuide for WFL

    COOPERSURGICAL TRIAL TRANSFER CATHETER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    AZUR CX DETACHABLE 18

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDIVATORS

    FDA Adverse Event
    Malfunction ·MEDIVATORS REPROCESSING SYSTEMS, DIV. OF MINNTECH·Product code FEB·December 13, 2010

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·January 22, 2013

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 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