BEUDAMED
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    SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NA

    FDA UDI
    Richard Wolf GmbH·04055207043363·RECTOSCOPE-OBTURATOR Ø 14.5MM TL 277MM TL 277m...

    SPIRA® Anterior Lumbar Spacers

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BRAIN HEART INFUSION AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 27, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·November 15, 2012

    SYNVISC (HYLAN G-F 20) INJECTION

    FDA Adverse Event
    GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·August 11, 2010

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 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