BEUDAMED
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    Betta Link Knotless Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NA

    FDA UDI
    Smith & Nephew, Inc.·00885556539682·MTOLAPAROSCOPE 5.5 X O DEG X 170 WL

    Dornier MedTech

    FDA UDI
    DORNIER MEDTECH AMERICA, INC.·00810116022748·Dornier 400 µm Single-Use ND YAG Laser Fiber 3.5m

    VEO® Lateral Interbody Fusion System

    FDA UDI
    Choice Spine, LP·00840996133616·LATERAL,BONE GRAFT INSERTER,SHEATH

    WRISTWATCH BLOOD PRESSURE MONITOR A46

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SCENARIA View

    FDA 510(k)
    FDA Class 2 ·Radiology

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·November 21, 2013

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·November 21, 2013

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·October 28, 2013

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·October 28, 2013

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 29, 2014

    CURRENT RF DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013

    PALMAZ GENESIS AMIIA

    FDA Adverse Event
    Injury ·CORDIS CORPORATION·Product code FGE·November 9, 2015

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 29, 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