BEUDAMED
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    Filters Regulation: Us FDA ×

    DYNA GARD SYRINGE FILTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209113651·

    POROUS TITANIUM ACETABULAR SHELLS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Molteno3 Glaucoma Implant

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    HEARTMATE II LVAS, EUROPE

    FDA Adverse Event
    Death ·THORATEC CORP.·Product code DSQ·May 23, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·October 5, 2010

    DUR MAR +4 10D LNR 36X60

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code LPH·November 30, 2012

    SEE H10

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDG·June 4, 2018

    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