BEUDAMED
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    PTT-LA TEST KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123830·K-WIRE - DOUBLE TROCAR 1.6mm DIA x 200mm

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123267·K-WIRE - DOUBLE TROCAR 1.6mm DIA x 100mm

    NOVATION LPI PRIME FEMORAL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

    FDA 510(k)
    FDA Class 2 ·Dental

    COBALT CHROME FEMORAL HEAD SZ 28 3.5MM 12/14 SHORT NECK

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JDI·December 15, 2016

    COCR HEAD SHORT NECK DIA28/-3. 5 MM 12/14

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code JDI·May 10, 2016

    BIOMET COBALT-CHROME FEMORAL COMPONENTS

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·March 17, 2017

    COBALT CHROME FEMORAL HEAD

    FDA Adverse Event
    Death ·BIOMET FRANCE S.A.R.L.·Product code JDI·August 31, 2017

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·ROCHE HEALTH SOLUTIONS INC.·Product code LZG·January 11, 2013

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·December 13, 2010

    INCEPTA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 9, 2014

    BIOMET COBALT-CHROME FEMORAL COMPONENTS

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code JDI·April 7, 2017

    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