BEUDAMED
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    IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)

    FDA 510(k)
    FDA Class 1 ·Microbiology

    P.F.C. SIGMA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295245537·P.F.C. SIGMA RP CURVED TIBIAL INSERT TRIAL SZ 5...

    AST S.C.E. (GOT)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTSTART FR3 ECG, BASIC BUNDLE, UKENG

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2014

    DISPOSABLE DISTAL ATTACHMENT

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code LFL·January 25, 2013

    FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SAN JOSE·Product code NFA·January 18, 2011

    BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

    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