BEUDAMED
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    CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL

    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

    MICROPAQ, MODELS 402, 404

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GLIDER PTCA BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    E1 RINGLOC BIPOLAR 28X51MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·June 17, 2019

    BIOMEX SHELL PC DIA48MM LN 22

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 2, 2015

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·May 29, 2014

    ACCU-CHEK SPIRIT

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

    CAPSUREFIX NOVUS

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

    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