BEUDAMED
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    FLEX FINDER GUIDEWIRE

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

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111116·KATENA INSTRUMENT RACK

    MULTI ANGLED ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    APEX MONORAIL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·December 14, 2010

    CORAIL AMT COLLAR SIZE 11

    FDA Adverse Event
    Injury ·DEPUY FRANCE·Product code KWA·January 22, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·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